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Career postings for the Massachusetts Biotechnology Council

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    Don't miss your chance to join a high-profile, public therapeutics company with programs advancing through the clinical process.  They are seeking experienced QC professionals to join their small, but growing, team as they develop their QC infrastructure and help advance life-saving therapies to market.  This role will be focused on cell-based/bioassay, flow cytometry, residual host cell protein and other non-traditional QC methods.    

    The main function of this role is to transfer, qualify/validate and troubleshoot test methods.

    Responsibilities include but are not limited to;
    •  Draft phase-appropriate qualification/validation protocols and reports  
    •  Review release and stability data and identify and investigate potential data trends
    •  Support process characterization activities and CMC sections of regulatory filings

    Formal descriptions can be supplied for interested candidates. 

    Qualified candidates will have a BS or MS degree in a life science discipline and 2-5+ years of experience.  The Hiring Manager has the ability to consider more experienced QC professionals and will title the role appropriately.  Strong knowledge of cGMP/ICH/FDA/EU regulations is also required.      

    Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.  

    All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.


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  • 11/30/15--08:50: Clinical Trial Manager
  • Our client, a clinical stage biopharmaceutical company, has an exciting opportunity for a Clinical Trial Manager to join their clinical operations team.  Are you able to lead program level activities while moving ahead with company wide activities and initiatives? This is an amazing opportunity for a motivated and detail oriented individual. 

     Requirements:

    • BS (health or life sciences) and experience
    • Experience in therapeutic Area: Oncology
    • Experience with maintaining and managing all tracking and trial databases, including budget, operational and quality standards for more than one trial at a time
    • Working knowledge of international conference on harmonization (ICH)
    • Global Clinical Trial Experience necessary

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™


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  • 11/29/15--22:33: Quality Engineer
  • Quality Engineer

    We are Regulatory and Quality Solutions LLC (R&Q) and we are the industry leader in providing regulatory and quality support to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices. Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the and means more.”

    Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family.

    Position Summary:

    We have a Quality Engineering position available in Boston, Massachusetts that will represent R&Q on client projects in the area of medical device QA/RA.  Some of the key accountabilities include:

    • Provide engineering support to ensure the quality of design, sourcing, manufacturing of products for the client.
    • Provide input to the development teams in the design of complex medical devices.
    • Develop, establishes and maintains quality engineering methodologies, systems, and practices to meet customer, and regulatory requirements.
    • Develop, apply and maintain quality requirements and standards for development and manufacturing products.
    • Design and implement methods for process control, process improvement, testing and inspection.
    • Promote and execute quality standards, inspection processes, test methodology, quality plans, documents and reports.
    • Develop, execute and analyze quality-reporting measures.
    • Establish supplier quality requirements.
    • Participate in internal and external quality audits.
    • Interface with supplier and customer quality representatives concerning problems with quality assurance and assure that effective corrective action is implemented.

    Education and Experience:

    • Bachelor degree in engineering or a technical field required; advanced degree preferred.
    • Working knowledge of FDA Quality System Regulations, EU Medical Device Directives and International Electrical Safety Standards required.
    • CQA/ CQE/ Certified Lead Auditor Training preferred
    • 5-7 years’ work experience; must have a minimum of 3 years’ experience in the medical device industry.
    • Experience conducting supplier quality audits, highly desired.

    Requirements:

    • Excellent time management and communication skills (written and verbal) – this individual will be speaking to many different individuals at various times
    • Ability to communicate both orally and in writing to both customers and staff in an effective manner.
    • Flexible and adaptable – the person in this position will experience rapidly changing plans and will need to quickly accommodate change
    • Previous experience in consulting preferred.
    • Willingness to travel, up to 100%.

    CLICK HERE TO APPLY


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  • 11/29/15--22:37: Software Quality Engineer
  • Software Quality Engineer

    We are Regulatory and Quality Solutions LLC (R&Q) and we are the industry leader in providing regulatory and quality support to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices. Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the and means more.”

    Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family.

    Position Summary:

    We have a Software Quality Engineering position available in Boston, Massachusetts that will represent R&Q on client projects in the area of medical device QA/RA. Some of the key accountabilities include:

    • Participated in New Product Development effort, either as an engineer or working on Software Quality.
    • Consult with product development to evaluate system interfaces, operational requirements, and performance requirements of overall system.
    • Maintain effective communication with the project software engineers on project limitation, capability, performance requirement and hardware interface changes.
    • Oversees design assurance activities; safety risk management, usability, design verification and design validation.
    • Review product design documentation to ensure that requirements stated are correct, unambiguous, and verifiable.
    • Leads the software design verification and design validation plans for products based on performance specifications and risk analysis.
    • Experience moderating Software Quality studies.
    • Define test methods and create test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions.
    • Execute test plans and create test reports to describe program evaluation, testing, and correction.
    • Monitor program performance after implementation to prevent reoccurrence of program operating problems and ensure efficiency of operation.
    • Conduct compatibility tests with vendor-provided programs.
    • Formulate and design software systems, using scientific analysis and mathematical models to predict and measure outcome and consequences of design.
    • Create test tools that facilitate data gathering and test method execution.
    • Recommend design improvements or corrections to engineers throughout the development process.
    • Prepares Software Design Requirements For New Products.
    • Participate in risk management meetings.
    • Leads root cause analysis investigations and drive continuous improvement efforts.
    • Authors complaint investigations to ensure timely completion and supported conclusions.
    • Provides daily regulatory and quality hands-on support to clients.
    • Support manufacturing by verifying fixture software or any software used during production.
    • Support clinical studies by validating data collection processes.

    Education and Experience:

    • Bachelors Degree in Electrical Engineering, Computer Engineering or equivalent technical Degree; or equivalent combination of education and experience.
    • Working knowledge of FDA Quality System Regulations, EU Medical Device Directives and International Electrical Safety Standards required.
    • Understanding of Experience with ISO 13485 and IEC 62304 and the practical application for Software Quality studies.
    • CQA/ CQE/ Certified Lead Auditor Training preferred.
    • 5-7 years’ work experience; must have a minimum of 3 years’ experience in the medical device industry.
    • Prior software quality assurance experience in a product development environment
    • Knowledge of C and Visual Basic Languages strongly preferred.
    • Mechanical: Experience with Pro-E and/ or AutoCAD.
    • Prior experience with designing, assessing, prototyping, and testing optical sensors.

    Requirements:

    • Excellent time management and communication skills (written and verbal) – this individual will be speaking to many different individuals at various times.
    • Ability to communicate both orally and in writing to both customers and staff in an effective manner.
    • Flexible and adaptable – the person in this position will experience rapidly changing plans and will need to quickly accommodate change.
    • Previous experience in consulting preferred.
    • Experience with C, C sharp or assembly-level code development, real time signal processing and I/O control.
    • High level of initiative with ability to self-manage.
    • Strong interpersonal skills with ability to work both independently and as part of a team.
    • Willingness to travel, up to 100%.

    CLICK HERE TO APPLY


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  • 11/29/15--22:40: Usability Engineer
  • Usability Engineer

    We are Regulatory and Quality Solutions LLC (R&Q) and we are the industry leader in providing regulatory and quality support to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices.  Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the and means more.”

    Being an industry leader in client support is just the beginning for R&Q. Providing a rewarding place to work is rooted deep in the core values of R&Q. From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the and means more” approach to employment. At R&Q, you are not just another employee, you are a member of the R&Q family.

    Position Summary:

    We have a Usability Engineering position available in Boston, Massachusetts that will represent R&Q on client projects in the area of medical device QA/RA.  Some of the key accountabilities include:

    • Understanding of design requirements, development, verification, and validation for medical devices.
    • Oversees design assurance activities; safety risk management, usability, design verification and design validation.
    • Participated in New Product Development effort, either as an engineer or working on Usability.
    • Prepares Design Requirements For New Products.
    • Experience with usability planning, usability testing, writing protocols, risk management, requirements development, tracing early stage user research.
    • Leads the usability plans for products based on performance specifications and risk analysis.
    • Experience moderating usability studies.
    • Works with customer marketing, engineering, manufacturing, and quality personnel to establish measurable, valid product usability requirements.

    Education and Experience:

    • Bachelor degree in engineering or a technical field required; advanced degree preferred.
    • Working knowledge of FDA Quality System Regulations, EU Medical Device Directives and International Electrical Safety Standards required.
    • Understanding of IEC 62366 and its practical application for usability studies.
    • CQA/ CQE/ Certified Lead Auditor Training preferred
    • 5-7 years’ work experience; must have a minimum of 3 years’ experience in the medical device industry.

    Requirements:

    • Excellent time management and communication skills (written and verbal) – this individual will be speaking to many different individuals at various times
    • Ability to communicate both orally and in writing to both customers and staff in an effective manner.
    • Ability to teach and mentor to teams regarding usability
    • Flexible and adaptable – the person in this position will experience rapidly changing plans and will need to quickly accommodate change
    • Previous experience in consulting preferred.
    • Willingness to travel, up to 100%

    CLICK HERE TO APPLY


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    Roles and responsibilities:

    We have an opening for a talented Senior Scientist at the Ph.D. or M.D. level to join the ImmunoOncology Translational Innovation Platform at EMD Serono, Billerica, MA. The successful candidate will be responsible for supporting the discovery and development of antibody, cytokine, and small molecule immunomodulators and immunomodulator combinations for the treatment of cancer using in vitro and in vivo experimental systems. A core responsibility would be to lead research studies across different stages of early stage pre-clinical discovery towards early clinical development. The Senior Scientist will be expected to have experience in tumor immunology models and cellular immunology assays. They will plan and execute experiments with the assistance of research associate staff in the ImmunoOncology platform.  The position requires someone who is proactive and innovative in defining new scientific, therapeutic, and technological strategies to enhance EMD Serono’s biologics pipeline.

    Expectations:

    • Design, execute and interpret studies on the development of antibody, cytokine, and small molecule immunomodulators and immunomodulator combinations for the treatment of cancer using in vitro and in vivo experimental systems
    • Collaborate effectively with  colleagues within the ImmunoOncology platform, across the global organization, as well as manage external collaborations with various industry partners
    • Contribute to multidisciplinary teams by designing functional, binding, pharmacodynamic assays to screen and characterize immunomodulatory antibody candidates and low molecular weight compounds
    • Work closely with established pre-clinical and clinical project teams to develop innovative pharmacodynamic and efficacy biomarker assays
    • Present scientific results to multidisciplinary teams and senior management
    • Bring expertise in a variety of rodent and human immunological assays including, flow cytometry, functional and molecular assays
    • Publish novel research findings in top-tier scientific, technical or medical journals
    • Represent the ImmunoOncology platform through presentations at internal and external meetings
    • Participate and thrive in an interactive, dynamic, team oriented culture
    • Attend meetings and conferences as needed to present data  

    Qualifications and Skills:

    A strong background in cellular immunology and immune regulation, preferably in the area of cancer immunotherapy, as evidenced by peer reviewed publications in top-tier journals, would be an important asset for this position. Experience with both rodent and human immune cell assays would also be an asset.

    • PhD degree in a relevant scientific field (e.g. immunology, cancer immunology, oncology)
    • A minimum of 1 year of post-doctoral experience in basic research either in an academic and/or industry setting
    • Consistent record of cutting edge research in cellular and/or tumor immunology, as evidenced by a strong publication and conference abstract record
    • Familiarity with tumor models and mechanisms of anti-tumor responses with strength in the analysis of the activity of innate and adaptive cell populations
    • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally
    • Team oriented work ethic and ability to work in cross-functional teams
    • Some prior experience managing research associates is preferred
    • Outstanding presentation and interpersonal communication skills
    • Ability to lead, influence and motivate others
    • Able to distill complex issues and clearly articulate innovative solutions
    • Ability to demonstrate effectiveness and growth in a fast-paced and dynamic team environment

    EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

    Equal Employment Opportunity

    The Company is an Equal Employment Opportunity employer.

    No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

    This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. 

    Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.


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    Roles and responsibilities:

    We have an opening for a talented Senior Scientist at the Ph.D. or M.D. level to join the ImmunoOncology Translational Innovation Platform at EMD Serono, Billerica, MA. The successful candidate will be responsible for supporting the discovery and development of antibody, cytokine, and small molecule immunomodulators and immunomodulator combinations for the treatment of cancer using in vitro and in vivo experimental systems. A core responsibility would be to lead research studies across different stages of early stage pre-clinical discovery towards early clinical development. The Senior Scientist will be expected to have experience in tumor immunology models and cellular immunology assays. They will plan and execute experiments with the assistance of research associate staff in the ImmunoOncology platform.  The position requires someone who is proactive and innovative in defining new scientific, therapeutic, and technological strategies to enhance EMD Serono’s biologics pipeline.

    Expectations:

    • Design, execute and interpret studies on the development of antibody, cytokine, and small molecule immunomodulators and immunomodulator combinations for the treatment of cancer using in vitro and in vivo experimental systems
    • Collaborate effectively with  colleagues within the ImmunoOncology platform, across the global organization, as well as manage external collaborations with various industry partners
    • Contribute to multidisciplinary teams by designing functional, binding, pharmacodynamic assays to screen and characterize immunomodulatory antibody candidates and low molecular weight compounds
    • Work closely with established pre-clinical and clinical project teams to develop innovative pharmacodynamic and efficacy biomarker assays
    • Present scientific results to multidisciplinary teams and senior management
    • Bring expertise in a variety of rodent and human immunological assays including, flow cytometry, functional and molecular assays
    • Publish novel research findings in top-tier scientific, technical or medical journals
    • Represent the ImmunoOncology platform through presentations at internal and external meetings
    • Participate and thrive in an interactive, dynamic, team oriented culture
    • Attend meetings and conferences as needed to present data  

    Qualifications and Skills:

    A strong background in cellular immunology and immune regulation, preferably in the area of cancer immunotherapy, as evidenced by peer reviewed publications in top-tier journals, would be an important asset for this position. Experience with both rodent and human immune cell assays would also be an asset.

    • PhD degree in a relevant scientific field (e.g. immunology, cancer immunology, oncology)
    • A minimum of 1 year of post-doctoral experience in basic research either in an academic and/or industry setting
    • Consistent record of cutting edge research in cellular and/or tumor immunology, as evidenced by a strong publication and conference abstract record
    • Familiarity with tumor models and mechanisms of anti-tumor responses with strength in the analysis of the activity of innate and adaptive cell populations
    • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally
    • Team oriented work ethic and ability to work in cross-functional teams
    • Some prior experience managing research associates is preferred
    • Outstanding presentation and interpersonal communication skills
    • Ability to lead, influence and motivate others
    • Able to distill complex issues and clearly articulate innovative solutions
    • Ability to demonstrate effectiveness and growth in a fast-paced and dynamic team environment

    EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

    Equal Employment Opportunity

    The Company is an Equal Employment Opportunity employer.

    No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

    This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. 

    Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.


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  • 11/29/15--23:54: Operations Assistant
  • Description Summary: Alcresta Pharmaceuticals is seeking a highly motivated and energetic professional to manage day-to-day office operations and provide administrative assistance to the Company’s executive team. This position reports to the Director of Operations

     Key Responsibilities: 

    • Manage all administrative activities to ensure the office is running efficiently
    • Manage activities related to ordering and receiving of office supplies
    • Manage day to day interactions with vendors including facilities, purchasing, IT, HR, finance, and legal service providers (w/supervision)
    • Handle business, company, and personnel details of a confidential and sensitive nature while engaging with high level contacts inside and outside the company
    • Help to maintain management team’s schedule by planning and scheduling meetings, conferences, teleconferences, and by coordinating domestic and international travel arrangements as well as handling preparation of expense reports
    • Assist in the design and preparation of corporate materials and presentations including the creation, editing and assembly of slides for presentations
    • Work closely with Board of Directors and their assistants for each quarterly BOD meeting

     

    Required Skills and Experience:

    • BS degree with a minimum of 4 years relevant work experience in an start-up setting, preferably biotech/pharma
    • Strong team player, results-oriented, experience in working in a start-up environment, including a “roll-up-the-sleeves” attitude to perform diverse tasks necessary (and multi-tasking) to achieve objectives
    • Excellent organization and time management skills
    • Excellent verbal/written communication skills
    • Previous experience in supporting senior executives
    • Requires expertise with Mac-based MS Office; proficiency in Word, Excel & PowerPoint required. Quickbooks desirable

     COMPENSATION

    • Hours and salary commensurate with experience, level of education, and competitiveness with market

     

     


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  • 11/30/15--00:23: Scientist
  • Ra Pharmaceuticals is a development stage Biotechnology Company with a platform that enables the discovery of novel therapeutics.  Ra Pharma combines novel insights into complement and other innate immunity pathways with leadership in macrocycle technology to transform the lives of patients with life threatening disorders. Our primary clinical focus is on diseases of complement dysregulation and orphan indications defined by validated biomarkers.

     

    Description:  We are currently seeking a Scientist with expertise in the complement system to join our Target Biology group.  Primary responsibilities will include the design, development, and execution of biochemical and cell-based assays for the characterization of drug candidates.  Additional responsibilities will include developing expertise in biology of targets and disease areas of interest and using this knowledge to advance projects as a member of a project team. 

     

    Qualifications: Candidates must have a Ph.D. in cell biology, molecular biology, biochemistry, or a related discipline with demonstrated scientific expertise in the biology of the complement system.  The successful candidate will be a flexible and careful scientist with leadership potential who is eager to learn and excited by the challenges and rewards of working in a highly demanding start-up environment. 

     


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    Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Within Medical Affairs, you will foster the medical/scientific connection between bluebird bio and key external stakeholders to further and enhance medical/scientific education and exchange.  Reporting to the Director, Medical Affairs, the Sr. Manager / Associate Director, Medical Affairs will serve as an internal medical/scientific consultant; play a central role in medical information, education, and training; and contribute to the overall development and execution of the Medical Affairs strategic and tactical plan(s) for bluebird bio’s gene therapy programs in hemoglobinopathies and/or adrenoleukodystrophy.  

    About the role:

    • Serves as a scientific & medical resource for cross-functional colleagues within the organization; provides medical & scientific insights to support strategic and tactical planning; sits on the Product Review Committee (PRC), reviewing externally-facing content for medical  & scientific accuracy
    • Builds, delivers, and regularly updates internal, cross-functional training platforms to educate bluebird bio on relevant disease areas, as well as the various gene therapy innovations being developed by the company, researchers in academia, and the competition
    • Assists in the development and oversight of the Medical Information function within Medical Affairs for responding to unsolicited requests from health care providers
    • Contributes to the development of medical communication resources, including but not limited to external engagement slide decks, standard response letters, and Q&A response documents

     

    About you:

    • Doctorate degree (MD, DO, PhD, PharmD) with 3 to 5 years working in a Medical Affairs capacity; experience in rare disease preferred
    • Experience developing medical communications and scientific training materials and programs
    • Ability to understand and assess complicated scientific and medical concepts, and review related materials for accuracy; Experience effectively communicating scientific and medical information to individuals and groups from various levels and functions of an organization
    • Excellent written and oral communication skills; Ability to anticipate and adapt to change; Strong interpersonal skills commensurate with the need to work closely with cross-functional partners
    • Ability to work independently, yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment
    • Readiness  to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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    Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Within Medical Affairs, you will foster the medical/scientific connection between bluebird bio and key external stakeholders to further and enhance medical/scientific education and exchange.  Reporting to the Director, Medical Affairs, the Sr. Manager / Associate Director, Medical Affairs will serve as an internal medical/scientific consultant; play a central role in medical information, education, and training; and contribute to the overall development and execution of the Medical Affairs strategic and tactical plan(s) for bluebird bio’s gene therapy programs in hemoglobinopathies and/or adrenoleukodystrophy.  

    About the role:

    • Serves as a scientific & medical resource for cross-functional colleagues within the organization; provides medical & scientific insights to support strategic and tactical planning; sits on the Product Review Committee (PRC), reviewing externally-facing content for medical  & scientific accuracy
    • Builds, delivers, and regularly updates internal, cross-functional training platforms to educate bluebird bio on relevant disease areas, as well as the various gene therapy innovations being developed by the company, researchers in academia, and the competition
    • Assists in the development and oversight of the Medical Information function within Medical Affairs for responding to unsolicited requests from health care providers
    • Contributes to the development of medical communication resources, including but not limited to external engagement slide decks, standard response letters, and Q&A response documents

     

    About you:

    • Doctorate degree (MD, DO, PhD, PharmD) with 3 to 5 years working in a Medical Affairs capacity; experience in rare disease preferred
    • Experience developing medical communications and scientific training materials and programs
    • Ability to understand and assess complicated scientific and medical concepts, and review related materials for accuracy; Experience effectively communicating scientific and medical information to individuals and groups from various levels and functions of an organization
    • Excellent written and oral communication skills; Ability to anticipate and adapt to change; Strong interpersonal skills commensurate with the need to work closely with cross-functional partners
    • Ability to work independently, yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment
    • Readiness  to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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  • 11/30/15--00:47: Director of Quality, GCP-GVP
  • Our local client, a dynamic growing biotech company, is seeking a highly collaborative and skilled Director of GCP Quality Assurance. There is huge potential here for growth for the right individual who exhibits strong leadership qualities.

    This critical hands on role will be responsible for full development and implementation and oversight of Good Clinical Practices & Good Pharmacovigilance Practices systems within this innovative company.

    The ideal candidate will possess an expert knowledge of GCP and a good working knowledge of GVP.  An individual with experience in building out and leading audit programs within these disciplines would be critical with this hire.

    Requirements:

    • BS or equivalent in a scientific discipline and 10 +years of relevant experience or an advanced degree and 7+ years of relevant experience
    • Experience holding a leadership position within a Quality department
    • Strong ability to communicate with senior leadership and presentation skills are a must.
    •  Excellent review skills and ability to multi-task in a fast-moving environment
    •  Able to travel up to 25% - some international travel will be required with the role.

     About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™


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    Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  In our bioinformatics group, you will develop next-generation sequencing (NGS) bioinformatics workflows related to MegaTAL nuclease design and off-target analysis.

    About the role:

    • Play the pivotal role in safety and efficacy assessment of reprogrammed MegaTAL nucleases.
    • Implement amplicon sequencing pipelines for nuclease off-target analysis, including automated selection of candidate loci, primer design, processing the resulting NGS data, delivery of the data to wet lab scientists.
    • Follow the genomics literature and independently suggest improvements to the above assays.
    • Contribute to other NGS bioinformatics projects, including whole exome association screen and viral insertion site analysis.
    • Improve the ways we present data, proactively seek feedback from colleagues in research, safety, clinical roles.

    About you:

    • Masters degree with 2+ years of experience or recent PhD.
    • Significant expertise in one or more of the following domains: (a) computer programming, (b) molecular biology, (c) statistics/machine learning, with minimal understanding of all three of them.
    • Knowledge of Python. Solid Linux user skills.
    • Experience with Illumina NGS data analysis and standard tools (QC, alignment, variant calling and annotation), understanding of the data formats and QC metrics provided by the instrument.
    • Thorough understanding of human genome annotation and the types of data available through RefSeq, ENSEMBL, ENCODE.
    • Knowledge of Perl, R and version control are a plus.
    • Basic frontend skills such as HTML, CSS, plain JavaScript and libraries/frameworks are a plus. Experience with Python back end options (Django, Flask) is useful.
    • Consider sharing some examples of your code, for example as a link to your GitHub, lab web site, open source project.
    • Ability to execute and follow-through to completion and documentation.
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated, detail oriented and good problem solving ability.
    • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
    • Excellent communication skills and ability to influence across multiple functions.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

    bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com

     

     


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  • 12/01/15--09:00: Director, Data Management
  • The Director, Data management, provides oversight of Clinical Data Management and Data Standards operations, including budget oversight, hiring personnel, managing personnel matters, and conducting performance evaluations for relevant staff. With the Manager and/or Associate Director, as applicable, the Director, Data Management, provides oversight of training activities to ensure that Clinical Data Management and Data Standards personnel receive adequate training to perform job responsibilities. The Director, Data Management, assists with resource allocation and the development of business proposals related to Data Management and Data Standards.  The Director, Data Management provides oversight of project-related data management and data standards tasks, and performs project-related tasks, as required.

     

    Primary Duties + Responsibilities

    • Develop and manage the yearly departmental budget for Data Management and Data Standards.  Meet with finance and the Executive team on a regular basis to present status updates on the department including the budget, resources, and process improvement initiatives.
    • Work with Clinical Data Managers (CDMs) and Data Standards Programmers to routinely monitor project activities against scopes of work to ensure operations are consistent with scope and assist with identifying changes in project scope or efficiencies to maintain timelines and budget.
    • Evaluate and monitor resources and develop resource allocation plan for all projects.
    • In concert with other senior staff, assess staffing and compensation requirements, assist in hiring and ensure appropriate training of Data Management and Data Standards personnel.
    • Support the development and implementation of Data Management and Data Standards Standard Operating Procedures (SOPs), guidelines, policies, procedures and ensure personnel are trained appropriately.
    • Oversee the implementation and management of data management systems and evaluate process improvements and innovative methods for clinical data management.
    • Interact with clients to provide a high standard of customer service and ensure complete understanding of Veristat’s data management and data standards responsibilities.
    • Represent Data Management and Data Standards in marketing efforts by developing project bid proposals, participating at bid defense meetings or performing client presentations as requested.
    • Facilitate communication and promote teamwork among team members.
    • Maintain a good working knowledge of clinical drug development, data management and data standardization in order to effectively serve as a department resource, develop training materials for Data Management and Data Standards personnel, conduct training sessions or otherwise enhance the skills and expand the knowledge of department personnel.

     

    Experience + Requirements

    • 10+ years of directly-related clinical data management/data standards or related experience; 3+ years of supervisory experience, to include data management and/or clinical operations.
    • Bachelor’s Degree required; focus in a health-related field or Registered Nursing degree preferred.
    • Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines (e.g., CDISC SDTM Implementation Guideline) as well as of medical terminology, clinical trials, and clinical research all required.
    • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies.
    • Skilled in use of computer technology, including clinical trial databases and applications and ability to learn new applications.

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    The Senior Data Standards Programmer conducts CDISC SDTM programming activities for clinical research projects from study start-up through submissions to regulatory agencies, works collaboratively across departments to produce quality deliverables within an agreed project timeline and budget, and assists with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. The Senior Data Standards Programmer may also serve as an SDTM migration lead within a project and/or program and provide guidance and expertize to clients and vendors on how to resolve technical issues at both a project and program level.   

     

    Primary Duties + Responsibilities

    • Participate on projects dealing with the assessment, design and/or implementation of data standards (e.g. CDISC SDTM and CDASH).
    • Perform Gap Analysis on studies requiring migration to CDISC standards to ensure all documentation and datasets necessary to perform the migration activities are present and without issue. Work with the migration team and client to resolve any issues.
    • Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
    • Follow standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets and Define.XML documents.
    • Assist in the development of Standard Operating Procedures (SOPs) and standard documents related to the implementation of data standards.
    • Ensure review of applicable project deliverables (e.g. protocol, case report forms, annotated case report forms, database structure, and statistical analysis plan) for consistency with data standards.
    • Liaise with Data Management, Biostatistics, and Programming personnel.
    • Assist with time and resource management for the completion of deliverables. Assist in the development and maintenance of a metadata repository.

     

    Experience + Requirements

    • Bachelor’s degree in a science or related field required. Master’s degree preferred.
    • At least 5 years of CDISC implementation experience and at least 5 years of SAS programming experience. Knowledge of XML programming is a plus.
    • Excellent working knowledge of CDISC SDTM Implementation Guidelines/Process.
    • Excellent knowledge of regulatory requirements and drug/device development process, especially on electronic data submissions requirements.
    • Extensive exposure to clinical trial data, SAS datasets, and database specifications.

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    Primary Role:
    The Regional Disease Education Manager (RDEM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RDEM will educate and raise awareness of specific Lysosomal Storage Disorders, Gaucher Disease and Hunters (MPS II) Syndrome, with health care providers in a defined geography to uncover patients that are appropriate for Shire's therapies. The RDEM will be expected to meet or exceed set expectations related to patient identification and the development of a robust sales funnel. Further, once an appropriate patient/provider is identified the RDEM will partner with the Regional Business Manager (RBM) to assist with the steps necessary to get the patient on drug.

    Responsibilities:
    This position will be responsible for all disease education related activities within their geographic responsibility, including achievement of MBO's, business planning in partnership with the RBM, and expense control. The RDEM will educate and inform HCPs on Gaucher Disease and Hunters (MPS II) Syndrome. They will describe signs and symptoms of the diseases and inform on the differential diagnosis process. They will educate HCPs on the appropriate treatment referral route. They will attend conferences and workshops as an exhibitor or presenter.

    Education & Experience Requirements:
    * Minimum of a Bachelor's degree in business or science related field is required
    * Healthcare provider, Nursing, Genetic Counselor background preferred
    Minimum of 4 years of sales experience required
    * Minimum of 2 in specialty biologics preferred
    Complex sales model experience is preferred
    * A consistent track record of success (Top 20% performance), President's Club or other top tier awards preferred
    * Experience providing complex disease education preferred
    * Rare disease experience is a plus
    * Demonstrated pioneering experiences required

    Demonstrates proficiency in the following key Shire Competencies:
    * Builds and Leverages Relationships
    * Demonstrates Business Acumen
    * Drives Results and Execution
    * Supports Our Regulatory Environment

    Other Job Requirements:
    * Candidate must live in territory
    * Must work evenings and weekends as needed
    * Extensive travel required and varies by territory
    * Candidates must possess a powerful sense of urgency, a strong desire for results and a strong work ethic.
    * Territory includes Michigan, Northern Indiana

    About Shire:
    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=bHZhaWwuMTA1NjkuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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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
    Performs administrative duties for executive management. Responsibilities may include screening calls; managing calendars; making travel, meeting and event arrangements; preparing reports and financial data; and customer relations. Requires exemplary organizational skills, strong computer and Internet skills, flexibility, excellent interpersonal skills, project coordination experience, and the ability to work well with all levels of internal management and staff, as well as outside clients and vendors. Sensitivity to confidential matters required.

    Responsibilities
    Manage day-to-day operational and administrative duties to support the Head of BioTx and NPRU.
    * Able to work flexible hours and to be accessible after hours as needed
    * Manage hectic calendar and meeting schedules, using prioritization skills and a high level of interpersonal refinement
    - Conserves executive's time by reading, researching, and routing correspondence; drafting
    letters and documents; collecting and analyzing information; initiating telecommunications

    Plan and optimize all travel plans for the Head of BioTx and NPRU.
    * Coordinate logistics and materials for meetings and presentations including offsite and all hands meetings
    Draft memos, letters, e-mails, documents and other responses as directed by the Head of BioTx and NPRU and BioTx & NPRU Head of Portfolio, Strategy and Communication.
    * Produces information by transcribing, formatting, inputting, editing, retrieving, copying, and transmitting text, data, and graphics.
    * Attend meetings, take notes, transcribe notes, derive action plans and follow up with all attendees to reinforce the meeting purpose, outcome and expected responses/actions

    Prepares reports by collecting and analyzing information.

    Gain a thorough understanding of all corporate goals, needs, personnel, processes and procedures

    Review and process expense reports and invoices

    Assist and perform ad hoc duties for the Head of BioTx and NPRU.
    * Maintain professional knowledge base and seek opportunities to enhance skills and abilities; seek new areas of responsibility and perform new tasks; recommend process improvements
    * Handle all duties with a high degree of integrity, professionalism and confidentiality
    - Welcomes guests and customers by greeting them, in person or on the telephone;
    answering or directing inquiries.
    - Demonstrate commitment to providing customer-focused quality service

    Perform other duties as assigned by the Head of BioTx and NPRU and BioTx & NPRU Head of Portfolio, Strategy and Communication.

    Qualifications
    EDUCATION AND EXPERIENCE -
    * High school degree or equivalent required plus 3 - 5 years' experience; BS/MS preferred
    * Experience as an administrative assistant or project manager required
    * Preferred C-level executive support experience
    * A healthcare background is beneficial.
    * Demonstrated proficiency in assigned technologies

    Prior Experience Preferred:
    * Excellent communication, interpersonal and influencing skills at a global, cross-line level.
    * Strategic planning and business analysis skills.
    * Demonstrated success supporting large and complex projects.
    * Demonstrated ability to transform collections of ideas into finished products and to manage a wide variety of activities while accounting for changing priorities.
    * Understanding of the drug discovery environment and scientific disciplines and how they fit into NPRU strategy.
    * Experience within the pharmaceutical research and development industry.

    TECHNICAL SKILLS REQUIREMENTS -
    Evidence of delivery
    Basic:
    * Superior attention to detail and able to multi-task and change priorities quickly
    * Strong sense of urgency and efficiency in completing work
    * Exemplary time management and prioritization skills
    * Must be able to maintain composure under pressure and manage unforeseen situations
    * Excellent judgment, problem resolution and decision-making skill

    Technical Ability
    Basic:
    * Excellent communication skills (verbal and written)
    * Ability to identify, propose and develop new solutions to further the effectiveness of the Head of BioTx and NPRU.
    * Excellent organizational skills with the ability to plan and execute projects

    Desired:
    * Passion for applying novel technology solutions to drug discovery and development
    * Evidence of desire for excellence and striving for constant improvement
    * Displays personal leadership to ensure success.
    * Proactively identifies opportunities for development of self.

    Desired:
    * Knowledge of the tools and processes used to develop the appropriate resources to
    * Support exploratory research
    * Proven track record of leading and delivering on multiple projects in parallel

    SharePoint; Microsoft Outlook, Excel, Word, PowerPoint, Project

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    This role requires flexible hours and to be accessible after hours as needed. Limited travel will be required.

    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=ZWRkeS5uaWNvbGFzLjM2MDkzLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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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
    Has responsibility for establishing and executing laboratory-based methods for assessing immunogenicity risk. Supports prediction of immunogenicity risk using various in vitro and ex vivo tools & evaluation of immunogenicity reduction technologies. Works in collaboration with PDM NBE (Pharmacokinetics, Dynamics, & Metabolism, New Biologics Entities) Immunogenicity Scientists, Project Representatives and other PDM-NBE disciplines to support Pfizer portfolio projects and to advance discipline science, technology and organizational goals.

    Responsibilities
    * Design, conduct and analyze results of immunogenicity assessment studies.
    * Organize and present data to inform decisions.
    * Establish new investigational methods to support science and technology advancement goals of the discipline.
    * Support continuous improvement of discipline operations.

    Qualifications
    * PhD level education in Immunology or BS/MS with experience in biopharmaceutical field with industry experience
    * Track record of method development skills particularly with novel and complex methods; track record of applying right tool to right problem
    * Practical experience of achieving results in a matrix environment.
    * Proven presentation skills, demonstrated through internal presentations on own work to discipline and project teams.
    * Formal education/training in immunology, biochemistry, cell biology, or related discipline.
    * Understand and in-depth experience with state of the art tools used to analyze immune response, e,g, multi-color flow cytometry with human cells, cellular immunoassay and other immunological methods, cell culture.
    * Strong data organization and analysis skills, both for Flow cytometry data
    * Collaborative skills and effective communication skills for a multi-discipline organization
    * Desired - 2 years post-doc experience
    * Desired - 2 years industry experience

    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=amlsbC5jdXR0aW5nLjU3NjIyLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


    0 0

    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 qualified candidate must have the experience and ability to participate in multiple projects within the Quality Control Microbiology group. Provides leadership on the interpretation of results and the design of follow-up studies. Independently support testing for commercial in-process cell culture, purification and bulk drug substance samples, environmental monitoring samples, raw materials, and process & cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements and per standard operating procedures.

    Responsibilities
    -Performs all work in compliance with cGMPs and site requirements.
    -Support routine environmental monitoring and water sample collection
    -Perform traditional microbiology testing (bioburden and LAL and/or microbial identification) in support of commercial product routine testing, investigations, method improvements, troubleshooting etc.
    -Validation of bioburden and endotoxin (LAL) methods and sample hold time during process validation for new products and raw materials.
    -Expansion of the use of rapid micro methods in the QC Microbiology laboratory (evaluation and feasibility studies).
    -Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation to resolve and correct.
    -Designs assays and experimentation in support of special study request or technology/material assessment.
    -Accountable for the accuracy and validity of testing results. Reviews and validates data. Interprets results, performs or reviews mathematical calculations, and records observations using Laboratory notebooks or other controlled documentation.
    -Trains less experienced analysts in new and existing procedures, techniques and governmental regulations. Mentors analysts by providing technical knowledge and support in resolving technical problems.
    -Oversees maintenance of all related records, and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner. Provides guidance to supervisor in prioritizing the testing activities of the group. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

    Qualifications
    -Bachelor's degree in Microbiology or related field with 3-5 years or MS with 1-3 years of industry experience, preferably in the biopharmaceutical industry.
    -Knowledge and practical application of relevant techniques - classical microbiology techniques as well as novel rapid microbial technologies (such as ScanRDI, DNA ribotyping , sequencing, and PCR).
    -Experience with technical writing, such as scientific reports, technical papers, method validation reports, etc.
    -Demonstrated ability to independently document and troubleshoot methods
    -Proficiency with Labware LIMS, MS Word and Excel.
    -cGMP experience is required

    PHYSICAL/MENTAL REQUIREMENTS:
    -The following physical abilities are required in order to fulfill the job duties:
    ­Ability to lift, pull or push equipment over 50lbs
    ­Repetitive bending and reaching to setup and break-down equipment
    ­Ability to climb ladders and work platforms
    ­Ability to walk and stand for periods of time

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
    -Working schedule: Thursday, Friday, Saturday, Sunday, Monday, 1st shift 8hours/day, start after 7:30am

    Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS42Nzk5My4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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  • 12/01/15--00:39: Research Associate I
  • We are seeking a full-time research associate for a minimum of 12 months to join a research project at the Broad Institute focused on applying CRISPR/Cas9 to understanding gene circuits in human cells. Experience in a biology wet lab, and especially in the below areas is highly relevant but not required: -DNA cloning (restriction cloning, Golden Gate, Gibson assembly) -standard mammalian tissue culture -DNA/RNA purification,

    Sanger sequencing, library preparation for Illumina sequencing -fluorescence microscopy (immunostaining, RNA FISH) -protein analysis (western blot) The ideal candidate is a quick learner with a demonstrated record of problem solving. Organization and communication skills are paramount. Programming skills are not necessary but considered a plus. Candidate will work closely with a senior graduate student and postdoc. Weekly project meetings will give the opportunity to discuss progress with the lab PI. In the latter six months, the candidate will be encouraged to pursue an independent project related to the research area. The duration of employment is one year, ending December 2016, with possible extension depending on performance and external funding applications.

    MINIMUM QUALIFICATIONS
    Bachelor degree in life sciences required and relevant research experience in related lab techniques.Ability to solve complex problems.Ability to exercise judgment within defined practices and techniques. Excellent communication skills and the ability to interact with all levels of staff and with external contactsExceptional organizational and critical thinking skills, lab notebook practices and attention to detail are essential.The Broad Institute will not offer visa sponsorship for this opportunity.

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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