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Career postings for the Massachusetts Biotechnology Council

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  • 12/13/15--23:22: Director, Statistics
  • Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  Reporting to the Vice President of Clinical Development Operations, the successful candidate will be responsible for scientific oversight from a statistical perspective for a novel gene therapy products in multiple therapeutic areas including hemoglobinopathies, CNS and oncology. 

    In this leadership position, the Director, Biostatistics will support drug development activities and decision making encompassing Phase I-IV, registries and Investigator Sponsored Studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements.    In addition, this person will select and oversee vendors and ensure they are performing to timeline and contractual agreements.

    About the role:

    • Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
    • Support Clinical Development Program teams as the biostatistical representative
    • Responsibility for statistical content in support of clinical study designs and regulatory interactions
    • Identify and implement emerging new ways of doing clinical development and new methodologies
    • Manage biostatistics vendors in the design, and analysis of clinical studies using appropriate and innovative statistical methods  
    • Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
    • Travel domestic and international 10-15%
    • Manage statistical programmers to deliver high quality statistical output for regulatory submissions, scientific abstracts/publications and clinical study reports
    • Participate in establishment and development of department SOPs
    • Maintain an active role in planning and preparation of regulatory submissions- briefing books and integrated summary documents
    • Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Development Operations management

    About you:

    • Ph.D. in Statistics or Applied Mathematics
    • 8-10 years of  clinical research and drug development experience
    • In-depth knowledge of methodologies applied in clinical trials with focus on early phase and registrational studies
    • Experience with patient registries is a plus
    • Extensive experience of interactions with regulatory agencies- US and Non-US
    • Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
    • Strong verbal and written communication skills; experience operating effectively within cross-functional teams
    • Flexible to changing priorities, detail-oriented, works well under pressure
    • Ability to communicate statistical information to non-scientists, willingness to educate internal team
    • Experience managing biometrics team, and resource planning 
    • Ability to work on  multiple projects and achieve deliverables and timelines
    • Excellent knowledge of GCP, ICH and FDA regulations
    • “Do-what-it-takes” approach to problem solving.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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    Who We Are

    ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

    The Opportunity

    The successful Clinical Scientist candidate will be a member of the clinical development team, working closely with other members of the medical research group in clinical development (medical monitor, statistician, clinical pharmacologist, translational research) to support investigations that deliver the development strategies for more than one drug.  The successful Clinical Scientist contributes to the trial development strategy assisting with protocol development and study design and clinical study execution.  The position will report to the Chief Medical Officer.

    Core Responsibilities:  The Clinical Scientist will be familiar with the latest thinking regarding oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements and will deploy this expertise in the execution of a number of key responsibilities:

    • Working with the Medical Director(s), to create key strategic documents including clinical development plans, protocol summary sheets and full protocols for defined product(s) along with amendments and related documents.
    • Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, and contribute to Clinical Development Plans
    • Performing medical data review during study execution to ensure integrity of accruing study data and appropriate SAE follow-up.
    • Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
    • Contribute to trial-related advisory boards.
    • Lead investigators meetings and protocol training meetings.
    • The Clinical Scientist is responsible for analyzing and interpreting study data from an individual study and translating study level clinical data across the program of studies for a particular drug, ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
    • Prepare and run dose escalation meetings with investigators (phase 1).
    • Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators.
    • Assist in forecasting trial resource needs (external costs).
    • Assist in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties.

    Who You Are

    • Master’s Degree, R.N., PhD, PharmD, or M.D. with clinical trial/drug development Phase 1-3 expertise highly desirable
    • Specific expertise in oncology/hematology required
    • The ideal candidate will have 5+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company and/or contract research organization
    • The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
    • Proven experience in developing effective relationships with key investigators

    ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

    ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.


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  • 12/13/15--23:34: Study Director, ESRS
  • Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device, and Biotech industries. 

    Job Summary

    Toxikon is seeking an experienced Study Director to work in the Efficacy and Surgical Research Services (ESRS) department.  The successful candidate will have extensive interaction with sponsors on study design, protocol development and technical execution and need to manage day-to-day activities of the studies.  They will be responsible for providing surgical research support in the area of anesthesia, operative procedures, pain management and post-operative care.  Additionally, as a Study Director, they will be responsible for the reporting of data.  Final reports should meet and exceed all turnaround times and will be responsible for the technical conduct of safety testing studies according to GLP/FDA/ISO and other various regulatory guidelines. 

    Essential Duties

    • Development of new test/surgical procedures, protocols and associated validations and services for the ESRS department. 
    • Assist/manage technical site visits of the department related to assigned projects and assisting Quality Assurance and Regulatory Affairs with all vendor/regulatory audits. 
    • Assist the Director of Veterinary Services/Attending Veterinarian in providing technical and clinical veterinary support to research projects and maintaining compliance with all State and Federal regulations (FDA, USA, AAALAC, MADPH and OLAW). 
    • Advise sponsors regarding animal models, species selection and special requirements with the development and use of animal/surgical models. 

    Minimum Requirements

    • Bachelors, Masters or DVM (or equivalent) required.
    • Experience with creativity in modeling of experiments for different applications and have strong technical lab experience. 
    • Highly motivated individual with good communication skills, computer skills and ability to analyze and solve problems. 
    • Independent thinker who can work well in a fast-paced, team oriented, GLP environment. 
    • An interest in collaborative and/or independent research is desirable. 

    To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=12962&lang=en_US&source=CC2 

    For additional information about Toxikon go to www.toxikon.com. 

    Toxikon offers a comprehensive benefits program including: paid vacation and sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

    Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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    Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium.  Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device and Biotech industries. 

    Job Summary

    Toxikon is seeking an experienced Study Director to work in the In Vivo Bio-compatibility department. The successful candidate will have interaction with sponsors on study design, protocol development and technical execution and interface with laboratory management regarding all day-to-day activities of the studies.  They will be responsible for providing technical and theoretical direction as the studies are being conducted.  As Study Director, you will be responsible for the interpretation, analysis, documentation and reporting of data.  Additionally, you will be responsible to ensure the technical conduct and regulatory compliance of your studies with FDA, GLP and ISO regulatory guidelines.  

    Essential Duties

    • Evaluate the medical device, component and/or material to be tested and ensure that all required documentation is accurate and in place prior to study initiation. 
    • Generate study protocols in compliance to United States and International regulatory testing guidelines. 
    • During the course of your studies you will work with Laboratory Management for scheduling and resource allocation as well as Research Associates to direct actions involving planned and/or unforeseen circumstances. 
    • Assemble all primary study data, for example clinical pathology, body weights, clinical observations, dosing records and histopathology and subsequently generating a comprehensive study report used for submission to regulatory agencies. 
    • Interface with sponsors on the best methods to evaluate individual products. 
    • Assist/mange technical site visits of the department related to assigned projects and assisting QAU and Regulatory Affairs with all vendor/regulatory audits. 

    Minimum Requirements

    • Master's Degree with 2+ years of experience or a Ph.D. (or equivalent) with 0-1 years experience in In Vivo pre-clinical study management and conduct.
    • Strong interpersonal skills in a diverse work environment.
    • Strong oral and written communication and presentation skills are key functions of this position. 
    • Comprehensive knowledge of Microsoft Office, in particular Excel, Word, PowerPoint and Outlook. 
    • The ability to multitask in a fast paced environment. 

    To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13365&lang=en_US&source=CC2 

    For additional information about Toxikon go to www.toxikon.com. 

    Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with a company match, medical, dental, vision, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

    Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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    Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches.  bluebird bio seeks an outstanding purification process development scientist to continue building our lentiviral vector manufacturing platform.  The candidate will have the opportunity lead a team through development, scale-up, and manufacturing.   We seek candidates with proven ability to successfully work independently and collaboratively across functions to meet aggressive project timelines, with the ultimate goal to deliver therapies that transform the lives of patients.

    About the role:

    • Planning and execution of viral vector purification development activities appropriate for large-scale GMP manufacturing
    • Screening, optimization and scale-up of chromatography (e.g. affinity, IEx, HIC, SEC) and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
    • Assist in technology transfer to GMP manufacturing by generating development reports, reviewing master batch records, and providing technical support.
    • Support our comparability studies for process improvements.
    • Responsibilities will also include in-process and final product characterization using cell-based and biochemical assays.  Analytical methods include qPCR, ELISA, SDS-PAGE, Western blotting, BCA, and HPLC.
    • Authoring and assistance in the technical review of supporting documents, reports, and change controls, including CMC sections for regulatory filings.

    About you: 

    • BS with 10+ years of directly related experience, MS with 6+ years of directly related experience, or PhD and 2 to 4 years of directly related experience.  Degree emphasis in Chemical Engineering, Biochemistry, Bioengineering, Molecular Biology, or related field preferred.
    • This is a hands on position requiring conducting laboratory experiments, good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function as needed.
    • An in-depth understanding of purification of biologics or more specifically viral vectors, including process scale-up and tech transfer.
    • Proficient with ÄKTA systems and UNICORN control software.
    • Experience with high-throughput process development techniques and statistical design of experience (DoE) strongly preferred.
    • Knowledge of GMP/ICH/FDA regulations.
    • Understanding of requirements for development of biologics including regulatory requirements for product comparability.
    • Track record of completing deliverables within specified timelines.
    • Ability to work effectively in a cross-functional team.
    • Demonstrated technical leadership skills.
    • Superb organizational and communications—both written and oral skills and “do-what-it-takes” attitude.
    • Experience in working with and managing outside vendors.
    • Understanding of analytical methods used to support biologics purification process development is needed.

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    Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium. Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device, and Biotech industries.

    Job Summary

    Toxikon is looking for an experienced Veterinary Anatomical Pathologist to join our pathology team.  The successful candidate will work hand in hand with our study directors, sponsors and technical lab staff to review histopathology slides/samples and generate well-written pathology reports.  This position offers a great opportunity to take part and review a wide variety of both toxicology and R&D studies.  As a CRO, Toxikon works with Sponsors from around the world testing an extensive variety of drugs and medical devices.  You will be joining a growing pathology team and will be selected based on your experience/aptitude and a dynamic personality.

    Essential Job Duties

    • Participate in on-going toxicology and R&D studies conducted in compliance with FDA and other national and international regulatory agencies.
    • Perform necropsy and histopathological pathology services involving a wide variety of laboratory animals, contributing to the development of study protocols and writing pathology reports.
    • Train department personnel in gross pathology and histology processing, devises and directs use of special stains and methods.
    • Actively participate in the discovery and characterization of mechanisms involved in experimental models and in the pre-clinical development and safety assessment of novel therapeutic agents.  This work will involve active communication with sponsors to best assess their needs.   

    Qualifications and Experience

    • DVM or equivalent degree and ACVP board certification required
    • Minimum of 3-5 years of experience in the CRO, drug development or device environments Toxicology and investigative pathology experience.
    • Solid understanding of medical device and pharmaceutical R&D.
    • Experience working under GLP guidelines is highly desired.

    Part-Time and Full-Time Positions available. 

    To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=11800&lang=en_US&source=CC2

    For additional information about Toxikon, please visit www.toxikon.com

    Toxikon offers a comprehensive benefits program including: paid vacation, sick and personal time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.

    Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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  • 12/13/15--23:50: Veterinary Care Associate
  • Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium.  Our mission continues to focus on providing quality pre-clinical services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries. 

    Job Summary

    Toxikon is committed to staying at the forefront of the life science product development.  The department of Pre-Clinical Veterinary Services is uniquely equipped to assist in the development of tomorrow's lifesaving medical devices and drugs.  Alongside our two vivarium's, our fully equipped surgical and procedure spaces offer the latest in surgical equipment, monitoring and imaging.  Located 20 miles outside Boston, all facilities are located on a single campus.  

    Essential Duties

    • Performing husbandry and enrichment activities for the non-human primate colony (NHP), maintaining NHP related records, performing and managing canine exercise and rabbit socialization programs, animal observation, nail trims, maintaining/reviewing animal room records and general animal colony management. 
    • Assist in maintaining veterinary procedure rooms, stocking supplies, and checking expiration dates and ordering drugs. 
    • Assisting the veterinary associates and veterinarians in the canine dental programs, NHP behavioral assessments, annual physical exams and clinical cases.

    Minimum Requirements

    • High School Diploma required.  Associates or Bachelor's Degree preferred.
    • A strong desire and experience working with animals. 
    • Highly motivated individual with good communication skills, computer skills and ability to analyze and solve problems. 
    • An independent thinker who can work well in a fast-paced, team oriented, GLP environment

    To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=13222&lang=en_US&source=CC3 

    For additional information about Toxikon go to www.toxikon.com. 

    Toxikon offers a comprehensive benefits program including: paid vacation, sick time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

    Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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  • 12/13/15--23:54: Web Application Developer
  • Toxikon Corporation, originally founded in 1977, is a Contract Research and Testing company with laboratories in Bedford, MA and Belgium. Our mission is to provide quality pre-clinical research services to Pharmaceutical, Medical Device, and Biotech industries.

    Job Summary

    Toxikon is seeking a motivated individual with strong problem-solving, teamwork, and time-management skills for the opening of web application developer. Qualified candidates will have a user-focused and standards-centric approach to web design and development, and will possess the ability to adapt in a fast paced technology environment.

    Essential Job Duties and Responsibilities:

    • Designing, implementing, operating, and maintaining web solutions for Toxikon’s business needs.
    • Providing training and support for using new and existing applications.
    • Modifying and maintaining applications for better alignment with requirements on an ongoing basis.
    • Staying current with new developments in web technologies.
    • Following best practices for system version control, testing, and release engineering.
    • Coordinating development work with other team-members in an Agile/Scrum environment.
    • Participating in development of and adherence to standards, processes, and guidelines to ascertain data integrity.

    Minimum Requirements:

    • Some experience in designing, planning, creating, and operating database driven web applications.
    • Familiarity with front-end development (HTML, CSS, JavaScript, Node).
    • Proficiency in application development using Python/Django or Ruby/Rails.
    • Knowledge of relational databases (MySQL, MS SQL Server or Oracle).
    • Familiarity with common software development methodologies and best practices.
    • Knowledge of web architecture and technologies.
    • Good understanding of computer science fundamentals such as algorithms and data structures.  

    Preferred Requirements:

    • B.S. in computer science or a related subject
    • 1+ years of experience in designing, planning, creating, and operating database driven web applications
    • Comfort with data processing and workflow automation
    • Expertise in integrating data storage components
    • Familiarity with web services (SOAP / REST)
    • Familiarity with database programming
    • Familiarity with ETL
    • Familiarity with Microsoft SharePoint
    • Some understanding of regulatory requirements for information technology in Pharmaceutical or Biotech industry

    To apply to this position go to: https://workforcenow.adp.com/jobs/apply/posting.html?client=toxcorp&jobId=11535&lang=en_US&source=CC2

    For additional information about Toxikon, please visit www.toxikon.com.   Toxikon offers a comprehensive benefits program including: paid vacation, sick and personal time, 401(k) plan with company match, medical, dental, vision care, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.  

    Toxikon is an equal opportunity employer.  As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state and local laws. 


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  • 12/13/15--23:58: Validation Manager
  • Join bluebird bio’s enthusiastic and collaborative Validation team to contribute to the overall success of our novel gene therapy. This position will support the organization through the establishment of bluebird bio validation/qualification programs and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. The successful candidate must be able to troubleshoot complex validation issues, and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer.  The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.  In this position you will also be responsible for guidance and technical review of protocols and reports related to equipment, test methods, computer systems, technology transfers, process validation, and transport validation activities. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.

     

     

    About the role:

    • Provide support and guidance for the development, execution, data analysis and reporting of clinical and commercial protocols as necessary.
    • Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
    • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
    • Ability to multitask and prioritize independently in a high paced environment.
    • Complete understanding of industry practices for product lifecycle.
    • Thorough knowledge and understanding of FDA and European requirements and expectations.
    • Ensures existing practices comply with industry standards.
    • Responsible for the alignment of the bluebird validation strategy and content with internal and external clients.
    • Author risk assessments and validation documentation in close collaboration with internal and external interfaces as necessary.
    • Provide validation support/expertise to CMC and Technology Transfer teams.
    • Responsible for supporting the development of process validation requirements for new product introductions through commercial scale.
    • Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
    • Contributes to the development of organizational objectives and principles.
    • Supports the development of long-range goals and objectives.
    • Exercises considerable latitude in determining objectives and approaches to critical assignments.
    • Acts as primary contact in absence of management.
    • Participates in the selection of contract support as necessary.
    • Provide management support and training to internal contractors.

    About you:

    • Wide range of expertise or working knowledge across all validation disciplines including process validation, shipping and cold chain storage, computer systems, method validation, facility utility systems and equipment (FUSE) along with cleaning validation.
    • Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
    • A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
    • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
    • Experience with Design of Experiments (DOE) approach for process development and characterization.
    • Prior experience with QbD initiatives and experience writing CMC documents and implementing QbD principles, tools, and processes is also required. Strong understanding of statistics and statistical tools including a track record of hands-on implementation of DOE as it related to QbD is strongly desired.
    • Leadership skills to lead cross functional teams to ensure project success.
    • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
    • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
    • Ability to travel approximately 25%.
    • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
    • Experience within a multi-product facility and/or Contract Manufacturing Business is a plus.
    • Validation experience using risk based approach (FMEA, PHA, etc.).
    • Project management experience.
    • Strong analytical ability.
    • Experience with Process Validation; experience with protocol development and execution; experience with presenting documents during inspections (regulatory agencies).
    • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
    • Ability to make independent sound decisions and independently manage priorities in alignment with departmental and corporate goals.

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  • 12/13/15--23:58: Validation Manager
  • Join bluebird bio’s enthusiastic and collaborative Validation team to contribute to the overall success of our novel gene therapy. This position will support the organization through the establishment of bluebird bio validation/qualification programs and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. The successful candidate must be able to troubleshoot complex validation issues, and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer.  The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.  In this position you will also be responsible for guidance and technical review of protocols and reports related to equipment, test methods, computer systems, technology transfers, process validation, and transport validation activities. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.

     

     

    About the role:

    • Provide support and guidance for the development, execution, data analysis and reporting of clinical and commercial protocols as necessary.
    • Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
    • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
    • Ability to multitask and prioritize independently in a high paced environment.
    • Complete understanding of industry practices for product lifecycle.
    • Thorough knowledge and understanding of FDA and European requirements and expectations.
    • Ensures existing practices comply with industry standards.
    • Responsible for the alignment of the bluebird validation strategy and content with internal and external clients.
    • Author risk assessments and validation documentation in close collaboration with internal and external interfaces as necessary.
    • Provide validation support/expertise to CMC and Technology Transfer teams.
    • Responsible for supporting the development of process validation requirements for new product introductions through commercial scale.
    • Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
    • Contributes to the development of organizational objectives and principles.
    • Supports the development of long-range goals and objectives.
    • Exercises considerable latitude in determining objectives and approaches to critical assignments.
    • Acts as primary contact in absence of management.
    • Participates in the selection of contract support as necessary.
    • Provide management support and training to internal contractors.

    About you:

    • Wide range of expertise or working knowledge across all validation disciplines including process validation, shipping and cold chain storage, computer systems, method validation, facility utility systems and equipment (FUSE) along with cleaning validation.
    • Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
    • A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
    • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
    • Experience with Design of Experiments (DOE) approach for process development and characterization.
    • Prior experience with QbD initiatives and experience writing CMC documents and implementing QbD principles, tools, and processes is also required. Strong understanding of statistics and statistical tools including a track record of hands-on implementation of DOE as it related to QbD is strongly desired.
    • Leadership skills to lead cross functional teams to ensure project success.
    • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
    • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
    • Ability to travel approximately 25%.
    • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
    • Experience within a multi-product facility and/or Contract Manufacturing Business is a plus.
    • Validation experience using risk based approach (FMEA, PHA, etc.).
    • Project management experience.
    • Strong analytical ability.
    • Experience with Process Validation; experience with protocol development and execution; experience with presenting documents during inspections (regulatory agencies).
    • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
    • Ability to make independent sound decisions and independently manage priorities in alignment with departmental and corporate goals.

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    bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.

    Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  The focus of this position is the development of the stem cell transduction and manufacturing processes. We are looking for a motivated scientist with the experience and drive to take ownership important process development projects.

    Activities include:

    • Design and execution of studies to improve all phases of drug product manufacturing processes, including large scale processing of bone marrow and apheresis, cell selection, transduction, cell washing and cryopreservation
    • Evaluation of automated cell processing systems
    • Analysis of cell phenotype by flow cytometry
    • All aspects of mammalian cell culture, including media and buffer preparation, culture initiation, propagation, and cryopreservation of cells, including primary human cells from commercial and/or patient sources 
    • Perform complex technical work related to stem cell biology, viral gene transfer, and molecular biology, including tissue culture and RT-PCR
    • Transduction of CD34+ cells with lentiviral vectors
    • Performance of general laboratory tasks, including maintenance of equipment
    • Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

    Preferred Qualifications:

    • PhD with 2 years experience, MS with 6+ years experience, or BS with 10+ years experience in cell biology, immunology, biotechnology or related field
    • Independently motivated, detail oriented and good problem solving ability
    • Excellent organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
    • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
    • Experience working with blood products
    • Well versed in a variety of cell based methods with a strong understanding of tissue culture, cell biology, immunoassays, and general laboratory techniques.
    • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals 
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
    • Willingness to work with lentiviral vector and human biological samples (viral vector biology experience a plus)
    • Ability to take ownership of study design, execution, data analysis and report generation
    • Manage to timelines
    • May direct work of other lab members
    • Working knowledge of various computer software, hardware, and standard office sufficient to record scientific data and results, and prepare reports.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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  • 12/14/15--00:15: SCIENTIST I
  • Who We Are

    ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com

    The Opportunity

    ImmunoGen is looking for a creative, energetic, and self-motivated Ph.D. scientist to join our Discovery group. The candidate will focus on target identification and validation efforts as well as support research and development of antibody-based cancer therapeutics.

    The breakdown of responsibilities is as follows:

    • Initiate projects to identify and validate new targets
    • Develop and implement new technologies for target identification/validation
    • Advance projects from discovery to pre-clinical development by working closely with other departments
    • Summarize and present research in internal and external meetings

    Who You Are

    • Ph.D. in Molecular Biology, Cell Biology or Immunology with 1-3 years of relevant experience
    • Broad knowledge of cancer biology and/or antibody therapeutics preferred
    • Prior hands on experience with cell-based and/or flow cytometry assay development is desired
    • Ability to work both independently and as part of a cross-functional team is required
    • Strong organizational, interpersonal and communication skills (oral and writing) are a must

    ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

    ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.


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    Who We Are

    ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

     

     

    The Opportunity
     

    • Coordinate demand and supply planning inputs and develop recommendations for internal manufacturing and external CMO manufacturing schedules to support the development programs.
    • Ensure that ongoing studies are able to be completed without stockouts or delays.
    • Work with Manufacturing management to develop and maintain internal Manufacturing Master Schedule.
    • Develop and maintain models and systems for managing the plans.
    • Develop and maintain Bills of Materials and Item Masters for internal batch manufacturing.
    • Analyze usage and recommend strategy for safety stock.
    • Proactively work with inventory control, purchasing, and Quality Control to ensure that materials are ordered, received, tested and released in a timely fashion to support the master schedule.
    • Analyze and balance material orders, costs, expiry and waste costs to ensure effective resource management.
    • Lead cross-functional Materials Team meetings and Demand & Operations Planning meetings.

     

    Who You Are

    • A minimum of 8 years in biopharmaceutical production planning in complex, multiproduct environment.
    • Bachelors degree in supply chain management, operations management or similar relevant discipline.
    • Expert at Excel spreadsheets and ERP system usage. ERP system implementation experience strongly preferred.
    • Demonstrated ability to work on and lead cross-functional teams within a matrix organization and to manage multiple organizational interfaces and stakeholders; and to influence and to be accountable for team output.
    • Strong analytical skills.
    • Communications: Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions.
    • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
    • Self-directed individual who is able to work effectively in a complex, fast-paced environment.

     

    ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

    ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

     


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    Director of Software Engineering

    T2 Biosystems, founded in 2006 by renowned scientists from MIT and Mass General Hospital, is an in vitro diagnostic company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies.     We are using our T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.  T2MR enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, and can detect cellular targets as limits of detection as low as one colony forming unit per milliliter, or CFU/ml.  Our initial development efforts utilizing T2MR target sepsis and hemostasis, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. We have completed a pivotal clinical trial for our T2Dx diagnostic instrument, or T2Dx, and T2 Candida panel, or T2Candida, which have the ability to rapidly identify the five clinically relevant species of Candida, a fungal pathogen known to cause sepsis.

    On September 22, 2014, T2 Biosystems received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.

    T2 Biosystems was named to the FierceMedicalDevices "Fierce 15" list in 2012, received the prestigious SBANE award in 2013 and received the Most Promising Company award at the Personalized Medicine World Conference in 2014

    We are seeking a talented and highly motivated individual to join our team as the Director of Software Engineering reporting to the VP of Engineering.  As a Director of Software Engineering, you will be responsible for leading a team of engineers in design, development, test, and deployment of the Company’s software applications.  This includes building a world-class team, setting standards, designing system architecture and implementing code. 

    Responsibilities:

    • Supervise and manage staff, including both software engineers and software QA engineers, and conduct performance reviews. Mentor, coach and maintain a best-of-class engineering team
    • Responsible for the overall software engineering life cycle of the Company’s software applications
    • Manage and execute against project plans and delivery commitments
    • Manage the day-to-day development activities of the software engineering team within an Agile/Scrum environment
    • Oversee software release management and engineering
    • Report on status of development, quality, operations, and system performance to management
    • A mixture of new product development and sustaining activities across multiple functional areas
    • Experience with FDA regulated environments is required.

     

     Education and Required Skills:

    • BS in Science or Engineering related fields
    • At least 9-12 years of progressively responsible experience developing software for a medical device or complex instrument.  At least 1-3 years of group management responsibility, including hiring. 
    • Strong technical credentials with hands-on architectural and system level design skill and experience
    • Strong drive and ability to motivate others and generate results in short project timelines
    • Commitment to test driven development, with experience setting up automated build and test systems a real plus
    • A strong track record of project delivery for large, cross-functional, projects
    • Excellent written and verbal communication skills with the ability to present complex technical information in a clear and concise manner to a variety of audiences
    • Comfortable with defining software verification and validation procedures in an FDA regulated environment

    The successful candidate will be highly motivated, results driven, exceptionally talented, analytical, and a team player. To apply, please follow the link to our careers page at: http://www.t2biosystems.com/careers/

    T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.

     


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  • 12/14/15--03:29: Medical Writer
  • Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways.

     

    Overview

     

    Infinity is looking for a motivated and experienced medical writer to join a three-person medical writing team responsible for clinical and nonclinical regulatory documents (e.g. study protocols, Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This position will contribute to an anticipated NDA filing in 2016, as well as assume lead writing responsibility for early and late phase clinical studies across multiple oncology programs. The position will contribute to key documents with regular exposure to senior management, with ample opportunities for growth and additional leadership. The ideal candidate would be primarily in-house, with flexibility to work from home part time.

     

    Responsibilities

     

    • Writes, reviews, and edits the following:
      • Regulatory Documents: Clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, IMPDs, NDAs, and other regulatory documents in conjunction with the project team
      • Publications: Manuscripts, abstracts, poster presentations, oral presentations
    • Drives document writing and review processes
    • Represents medical writing function as an integrated member of clinical study teams
    • Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
    • Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization
    • May manage outsourced writing projects with contract medical writers
    • Assists in the development and maintenance of SOPs and writing tools, such as templates and style manuals
    • Provides training on medical writing templates, SOPs, and processes within the department and across departments
    • Provides quality control (QC) review of various regulatory and medical communications documents
    • Provides project team(s) with guidance and problem resolution related to document generation
    • Takes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
    • Acts as an authoritative resource within specialty area to internal and external resources
    • Works effectively with colleagues from other departments in team situations
    • Very little travel is required, with exceptions for career growth opportunities (DIA, AMWA, etc) and attendance of key conferences, such as the American Society of Hematology (ASH), the American Society of Clinical Oncology (ASCO), and the American Association for Cancer Research (AACR)

    REQUIRED QUALIFICATIONS:

    • Bachelor’s degree
    • 3 years of medical writing or editing experience
    • Ability to understand and summarize clinical data
    • Expertise in MS WORD, with the ability to solve technical problems with documents and templates
    • Knowledge of FDA and ICH guidelines
    • Adept communication skills (both written and oral)
    • Basic knowledge of science and clinical research
    • Familiarity with industry trends for clinical documents and international dossier preparation, including electronic document submissions
    • Experience working on complex projects, within cross-functional teams

     

    PREFERRED QUALIFICATIONS:

    • Master’s Degree or higher in a science-related field or English
    • 3 years of medical writing or editing experience in the pharmaceutical/biotechnology industry
    • Proven ability to act as lead author on different types of clinical and regulatory documents
    • Experience contributing to global submission, such as NDAs and MAAs
    • Working knowledge of the eCTD format

    To apply, please visit our website at http://www.infi.com


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  • 12/14/15--03:33: Clinical Scientist
  • CLIENT:: Biotech Company

    Compensation: $$ Salary, Depending on individual's current compensation (meet and exceed)

    -------------------------------------------------------------------------------------
    The Clinical Scientist will provide scientific, pharmacologic and/or medical input into company publications, trial designs and protocols across all stages of clinical development and support regulatory submissions worldwide. This person will work with cross-functional teams and global collaborations to integrate broad medical and scientific input into assigned development programs. This individual will work with clinical research, translational, program management, regulatory and operational staff (among others) to develop and implement protocols, publications, presentations and submissions that advance clinical development plans for assigned programs and molecules.

    This role will work with cross-functional and global collaborations to integrate broad medical and scientific input into company’s development programs and clinical development plans for assigned programs and molecules. Depending on corporate/programmatic needs and individual aptitudes, the role may primarily focus on Safety, Clinical or Scientific Research aspects of assigned programs.

    Project work and responsibilities as appropriate to skill set, including:
    Prepare and/or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal and external presentations;
    Prepare synopses and protocols (writing, reviewing, amending and cross-functional facilitation as appropriate);
    Participate in clinical development plans for assigned compounds;
    Review safety, primary efficacy variables, and laboratory data
    Review scientific literature and prepare presentations, regulatory submission documents, etc.;
    Collaborate with and support interactions with clinical sites as needed; and
    Review clinical data including: safety, primary efficacy variables, and laboratory data.


    Minimum of 2 years’ experience working in a technical capacity (eg, RN, PharmD, DO, MD) in biotech, pharmaceutical industry, clinical setting or equivalent;


    Minimum of 1 year working in a data-driven environment;
    Oncology experience required;

    Working knowledge of clinical trial design and execution;
    Experience in protocol development and regulatory submissions;
    Adherence to the highest standards for trial conduct, patient safety and data integrity;

    Medical/technical writing and basis statistics expertise preferred;
    Working knowledge of GCP, ICH Guidelines and standard medical terminology;

    Facility with Microsoft Office applications (eg, Excel, Powerpoint);
    Proficiency in literature searches and standard data mining, interpretation and presentation;
    Ability to assimilate technical and scientific information accurately and quickly;
    Able to work with cross-functional teams and meet deadlines in a fast-paced work environment;
    Outstanding written and verbal communication skills; and
    Meticulous and well-organized.


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  • 12/14/15--22:23: Recruitment Nurse
  • Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    The Recruitment Nurse is responsible for all activities associated with the contact, screening, scheduling and recruitment of clinical trial subjects and patients. Responsibilities include:
    *Overseeing the development, growth, cleaning and maintenance of the subject database;
    *Phone screening of volunteers and patients for trials requiring a health professional’s initial assessment of eligibility for the study;
    *Recruitment and screening activities, as well as support of clinical trials
    Liaising with Director of Clinical Operations and recruitment department to ensure continuity of work flow and communication between recruitment and screening

    Responsibilities
    Subject/Patient Database Maintenance
    *Develop and implement process for phone screens to update healthy volunteer and patient demographic data in the CRU database; include assignment of weekly/monthly goals;
    *Implement process for ongoing maintenance of subject database;
    *Query database for certain subject populations; subject matter expert in screening queries, use to contact volunteers (letters, emails)

    Recruitment and Screening Activities
    *Provide support to internal clinical research staff in the pre-selection of subjects for eligibility using protocol inclusion/exclusion criteria;
    *Communicate protocol requirements to study subjects and patients calling to inquire about specific studies;
    *Create and manage all communication methods to subjects, including but not limited to letters, text messaging, and mailings;
    *Manage subject phone calls including scheduling/rescheduling of appointments;
    *Recruit required number of subjects for specific studies;
    *Ensure phone screening department maintains a positive and professional attitude to the subject population, understanding they are the first contact subjects have with the CRU;
    *Track phone call metrics from sources of advertising so that advertising strategies can be decided based on what is most effective;
    *Create new ways to recruit volunteers and patients
    *Develop study specific and general ads
    *Coordinate and manage ad placement in various venues (social media, newspaper)

    Other
    *Establish strong collaborative relationship with recruitment department to realize shared goals in recruitment of subjects for CRU clinical trials;
    *Demonstrate creative thinking in suggesting new or more effective ways to recruit volunteers and patients for clinical trials;
    *Demonstrate leadership skills in building a quality recruiting department;
    *Active participation in CRU department and other meetings;
    *Community outreach efforts- evaluate appropriate venues for target population and attend events
    *Assist in development and maintenance of social media presence including website updates
    *Participate in PCRU teams to accomplish business needs and resolve issues
    *40 hour position; may include some weekend and evening hours;

    Qualifications
    *Registered Nurse or Licensed Practical Nurse, or related discipline, required
    *Previous supervisory experience required
    *Health care practice experience/training with valid license, preferred
    *Spanish language fluency strongly preferred
    *Excellent written and verbal communication skills
    *Excellent computer skills
    *Excellent customer service and professionalism
    *Strong management skills

    PHYSICAL/MENTAL REQUIREMENTS
    *Off shift and weekend hours
    *Community outreach (i.e. health screenings, participating in patient advocacy groups, networking with physician offices)
    *Transporting recruitment materials and setup items to various community events

    Application URL:http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS45MTQ1OC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    This research position is located at the department of Global Biotherapeutics Technologies in Pfizer Worldwide Biotherapeutics Research campus at Andover, MA. This individual will work in the area of therapeutic protein production and engineering in mammalian cells. The individual will perform molecule biology, mammalian cell culture, large-scale bioreactor mammalian cell expression, and protein production analysis for supporting protein therapeutics discovery efforts. The individual will perform this function with supervision, toward considerable independence, and will display initiative in learning new techniques.

    Responsibilities
    - Carry out molecular biology, mammalian cell culture, transient/stable transfection, expression analysis with ProA capturing, analytical SEC, immunoblotting, and scale-up in bioreactors.
    - Maintain and operate 10L - 100L bioreactors for cell culture scale-up, and perform downstream medium clarification.
    - Perform calculations and draws conclusions regarding progress and results of work.
    - Assist with the organization and maintenance of cell line stocks and plasmid DNA stocks.
    - Quickly learns and accurately performs new procedures involving a range of technologies.
    - Demonstrate oral and written presentation skills.
    - Prepare and present project summaries at team meetings, GBT meetings, and through monthly summary reports.
    - Contribute to the preparation of papers for peer review journals.

    Qualifications
    - A Bachelor’s Degree is required, preferably with a Life Science major.
    - A Bachelor’s Degree and a minimum of 1-5+ years of relevant laboratory experience, or a Master’s Degree with 1-5+ year of relevant laboratory experience.
    - Mammalian protein expression experience, large-scale CHO/HEK293 stable/transient expression experience is preferred.
    - Training in molecular biology and/or mammalian cell biology and experimental experience using cell culture techniques.
    - Understanding of the principles involved in molecular and cellular biology and/or cell culture techniques.
    - Demonstrated capability to conduct complex experiments in parallel.

    PHYSICAL/MENTAL REQUIREMENTS
    Lab based position. Maintain and operate 10L - 100L bioreactors.

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy42Nzg2NC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    *Leads the cross-functional execution of one or more clinical studies conducted within the Pfizer Clinical Research Unit (PCRU)
    *Accountable to PCRU leadership and the Core Study Team for delivery of a PCRU study according to agreed quality, timeline and cost parameters
    *Assures that PCRU studies are conducted in compliance with GCP, relevant SOPs and local regulatory requirements
    *Assures data integrity and data quality for each assigned study through input to study feasibility and protocol development efforts, verification of EDCMS study set up, management of cross-study activities and coordination of PCRU functional line data review/verification activities (e.g., data verification, data cache review, data listing reviews, study report reviews)
    *Coordinates and contributes to the assessment and minimization of operational risks and to the resolution of operational issues
    *Promotes best practices within and across PCRU studies to drive operational excellence

    Responsibilities
    *Responsible for study/project management within the unit including study scheduling, protocol planning(startup activity) and is the primary contact for the project teams responsible for the compound/project - from the time of the Study/project document is drafted until the data base/project is locked.
    *Leads PCRU cross-functional input to, and review of, the Study Protocol prior to finalization
    *Serves as primary liaison/point of contact for the Core Project Teams/Pfizer Clinical Research Unit (PCRU)
    *Develops and ensures adherence to study timelines
    *Coordinates and reviews all study activities
    *Serves as primary point of contact for on study decisions related to the protocol, data collection and volunteer activities
    *Partners with line leaders and functional staff across PCRU departments
    *Maintains accuracy, accessibility and confidentiality of all volunteer records and reports
    *In depth review of all clinical data, serves as study monitor, ensures all data is complete and checked before databse lock and release
    *Leads the data integrity/data quality activities for assigned protocols
    *Reviews Informed Consent Document for IRB submission
    *Provides critical assessment of strategic partner and vendor proposals to ensure study success
    *Reviews site level clinical trial budget
    *Leads other functions and strategic partners to ensure timely delivery of quality data
    *Oversees the overall execution of clinical studies
    *Participates in study meeting with relevant partners for operational alignment
    *Communicates opportunities and risks to the Core Project Teams for integration in risk management plans
    *Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals
    *Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines. Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities
    *Leads the clinical study components with respect to time, operational feasibility, and study-level PCRU resources required to deliver individual studies against the development plan (part of the study budget)
    *Assesses impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure conduct and data collection suitable for purpose
    *Provides support for Methodology/Mechanistic studies as appropriate
    *Partners with Core Project Teams to provide study schedule and budget information to enable project management
    *Identifies performance/quality issues to develop appropriate remediation plan
    *Identifies and escalates system or process issues affecting deliverables
    *Manages the creation and detailing of all study activity/source documents.
    *Leads the quality control of all study related activities for assigned protocols
    *Assures data integrity and data quality in assigned studies
    *Accountable to PCRU leadership for the highest quality of data in clinical trials
    *Manages all data queries specific to subject data collection
    *Supports EDCMS setup; assures EDCMS Setup reflects requirements of final approved protocol or approved amendment(s)Assures staff perform necessary data quality and review checks
    *Reviews data output over the course of the study and escalates any noted issues to the appropriate staff member or line leader
    *Leads a systematic review of all study data prior to database lock to assure the absence of data issues
    *Other Responsibilities
    *May represent the unit on Global initiatives (Global SOP’s, process improvement teams, other activities as they present themselves) as they are the subject matter experts in the Unit.
    *May Lead PCRU teams in accomplishing business needs and resolving issues
    *May represent the PCRU as a subject matter expert for internal/external resource (provide support to external center, etc.)
    *Participate in study and staff scheduling for assigned protocols, as appropriate
    *May participate in study related data collection activities as needed
    *Oversee creation and detailing of study activity documents for staff & volunteer use
    *May mentor/coach other staff

    Qualifications
    *Minimum of BA/BS in a biomedical discipline or equivalent education/training is required; advanced training/education preferred
    *Relevant experience in clinical research and drug development with clinical operations experience required. Specific direct experience in early drug development (Phase I and IIa) preferred.
    *Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
    *Experience in Project Management and leadership of matrix teams is essential
    *Drug development experience including familiarity with: Clinical study management and monitoring , Project/process management, Data management, Clinical & regulatory processes, Regulatory submissions, Budget / expense management, Experience of Vendor Management, Scientific excellence, Administrative excellence, Systems technology
    *Initiating and Implementing Change: Innovation, Learning Organization, Flexibility and Resilience, Courage with Decisiveness to Act, Problem Solving, Positive approach, forward thinking, challenge the status quo
    *Matrix leadership skills: Influencing, Collaborative, supportive, Networking and Alliance Building, Personal Leadership, Team work, Communication, Negotiation, Decisive and assertive, Change agile, Able to deal with ambiguity
    *Proficiency in using MS Office tools suite (Excel, Word, etc.)

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS4zMzQ2Mi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    Candidate will be responsible for independent execution of scientific research and/or development strategies in a Precision Medicine biomarker focused flow cytometry laboratory. This scientist will act as a scientific expert regarding cellular markers using FACS and cell imaging technologies for preclinical biomarkers, as well as translation to support Pfizer clinical candidates. Candidate will provide flow cytometry data for biomarker discovery and support assay method development and standardization. Candidate will participate with PM teams and research units in a matrixed environment. This scientist should have proven experience in the delivery of flow and cell imaging-based biomarkers in preclinical studies, and have strong knowledge of biological systems and cellular function to enable Pfizer discovery and development objectives.

    Responsibilities
    *The successful candidate will have experience developing partnerships in a matrixed environment, influencing project strategies.
    *Responsibilities include independent planning of laboratory activities, understanding and influencing therapeutic area biomarker strategies to use biomarkers in scientific decision-making.
    *Candidate will participate in all phases of FACs laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
    *Proactively gathers input from colleagues, teams & management to avoid/address issues at functional level and participates on cross discipline matrix teams.
    *Excellent oral/written communication skills
    *Demonstrated ability to clearly & concisely communicate bioanalytical information (including Q&A)
    *Ability to effectively balance assay rigor against resource needs and study goals. Understanding of “fit-for-purpose”
    *Publications in peer-reviewed scientific journal and poster presentations will be a plus.

    Qualifications
    B.S. Minimum +3 yrs relevant experience conducting research based on flow cytometry studies in pharma and/or biotech enviroments. Experience in development assay, biomarker studies and flow data analysis. Ability to succeed in a small, interactive, highly matrixed environment. Experience in one or more research areas of interest (Immunology, Cardiovascular).

    Technical Skills:
    Deep knowledge of BD flow cytometers (Fortessa, Canto, etc), imaging flow cytometry is a plus
    - Strong Cellular and Immunobiology background
    - Track record in Flow cytometry assay development
    - Ability to design experiments, execute on plans, and interpret results in an independent manner
    - Strong written and oral communication skills
    *Experience and track record in operation of modern flow cytometry, Image Flow cytometer and Flow softwares (FlowJo, Cytobank)
    *Track record of immunoassay techniques as applied to flow cytometry techniques
    *Experience on sample preparation methodologies as applied to flow cytometry techniques
    *Good understanding of biochemistry, Immunology and cellular biology.
    *Experience and track record on flow cytometry assay development and biomarkers.
    *Good written and oral skills.

    PHYSICAL/MENTAL REQUIREMENTS:
    Lifting, sitting, standing, walking.

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=TWVnYW4uSGFycmlnYW4uNzQ2ODEuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t


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