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Career postings for the Massachusetts Biotechnology Council

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  • 01/21/16--00:25: Sr. Analyst, FP&A
  •  

    The successful candidate will serve a critical role for the Business by being responsible for the administration of our Hyperion Budgeting and Planning System, along with being the financial business partner for all G&A functions within the business. Reporting to the Senior Director of FP&A you will be responsible for creating and maintaining templates and reporting for the annual budget, forecasts and the Long Range Plan, monthly reporting for the G&A function and ad hoc analysis to help the business better understand costs and trends. Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

     

    About the Role:

    • Maintain the Hyperion budgeting and planning system
    • Create and maintain financial reports for the Business
    • Be the financial point of contact for all G&A functions
    • Prepare and enhance monthly functional reporting packages
    • Partner with the G&A functions to establish budgets and forecasts
    • Coordinate monthly headcount reporting and forecasting with the Human Resources Department
    • Work with all functions in the business to develop robust capital expense budgets and forecasts
    • Special projects and ad-hoc analysis as needed

     

    About you:

    • Degree in accounting or finance, MBA/CPA a plus
    • 3-5 years of experience
    • Excellent knowledge of Hyperion budgeting and planning
    • Strong knowledge of the MS Office Suite
    • 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

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    BioScale is seeking an Applications Sales and Marketing Manager to:

    • Work closely with the commercial leader on strategic products and services, including define new products;
    • Develop marketing collateral and product documentation as well as sales execution in the field;
    • Work with the internal technical team to develop and launch new products and services; and;
    • Coordinate support of existing customers.

    This role provides opportunities for assuming broad responsibilities and independent execution and decision making. The successful candidate will:

    • Work with commercial leader on strategic services and product development and execution in the field;
    • Think strategically about the business, process and priorities to develop product and/or service offering;
    • Be part of the market development effort to launch CRO service capabilities;
    • Develop marketing campaigns to target and attract new customers;
    • Support companies Dx product commercialization efforts where synergistic; 
    • Manage customer relationships for evaluations, lead sales and service efforts, including technical aspects;
    • Generate and process leads to develop a sales pipeline;
    • Write proposals including technical work plans, oversee proposal review process and drive toward sales close;
    • Oversee execution of projects, present technical data to customers and pursue follow-up sales;
    • Understand customer decision factors and digest, synthesize and share in-depth customer knowledge across the Organization;
    • Technology and application development and Team player - contribute to internal technical programs fostering technology and application development, and;
    • Translate customer requirements to product or service specs for new or enhanced  products.

    Experience

    • 5+ years of field lab applications or market applications development supporting marketing or sales teams in a life sciences or drug development Organization;
    • A bachelor’s degree or equivalent in a Life Science or related discipline (Cell Biology, Molecular Biology, Biochemistry or Biotechnology).  MBA or other graduate degree beneficial;
    • Demonstrated track record of execution and achievement in the lab, applications marketing or applications scientist roles in a commercial environment;  
    • Awareness and understanding of the Life Sciences Industry including: biotherapeutic drug development process, precision medicine, and molecular diagnostics;
    • Strong leadership and motivational capabilities to maintain team focus, engagement, and follow-up;
    • Capability to effectively influence, relate to and communicate with both peers and management with concise communication that will advance sales opportunities and satisfy customer requirements;
    • Exceptional analytical and critical thinking capabilities and be a self starter with good work ethic;
    • Capacity to build strong relationships and collaborative partnerships with cross functional partners to execute on shared goals;
    • Able to cope with high peak workloads, short deadlines and significant pressure;
    • Ability to travel ~ 10 - 30%;
    • Proficient in life sciences, CRO or Dx companies specifically: marketing, business & financial acumen, analytic ability, market & competitive knowledge, customer insight, segmentation, communication channels, value proposition, campaign & program development, and;
    • Sales experience in reagents, consumerables, CRO services a plus.

    Interested?  Forward resumes and cover letters to hr@bioscale.com or mail resumes to Human Resources, BioScale, Inc., One Fortune Drive, Billerica, MA  01821.   

     


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    Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Research Associate - Cell Culture

     

    Codiak Biosciences is seeking a upstream scientist/biochemical engineer to help develop the company’s novel cell culture bioprocessing platform.  Responsibilities will include providing technical/scientific expertise and lab support in all upstream areas, such as cell line development, clone selection, cell banking, inoculum expansion, bioreactor operation, high throughput technology, cell characterization, media development, etc.  Background in downstream processing, bioanalytics and cell-based assays, will be a plus.  Understanding of exosome biology, isolation and characterization will be an additional advantage.  This is a unique opportunity for a strong scientist/biochemical engineer to contribute experimentally and intellectually to both early- and late-stage development of Codiak’s novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the lab.

     

    Qualifications

     

    The candidate will have a degree in cell biology, biochemical engineering or a similar discipline.  The successful candidate will have the ability to work well independently, or as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments.  Additional qualifications include excellent interpersonal and presentation skills.

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome technology are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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  • 01/21/16--01:07: Director of Biology
  • Position Title: Director of Biology

     

    Position Overview

    • Unique growth opportunity for seasoned biology leader with at least 5+ years of experience in an industry-based drug discovery setting.

    • Requires leadership experience gained through leading multidisciplinary research teams in drug discovery using in vitro and in vivo models and methodologies.

    • Must have expertise in small molecule therapeutic development from hit identification to clinical development candidate

    • Track record must include strategic leadership, innovative scientific solutions, productive collaborations, and excellent communication and mentoring skills.

    •  Specific job functions:

    • Driving current drug discovery projects from high throughput screening, through lead optimization to clinical development candidate
    • Supervision of a team of research biologists from technician to senior PhD level
    • Participating in internal cross-team collaborations and acting as point for collaborative alliances with academic and industry partner organizations.

    • Will promote a collaborative team-focused work environment dedicated to conducting high quality research, providing mentorship, leadership and drug discovery expertise.

    • Ideal growth opportunity for a biologist who is well recognized in the drug discovery community as an innovative research scientist and leader.

     

    Qualifications & Skills
    • PhD degree in pharmacology, cell and / or molecular biology, biochemistry, or related field
    • At least 10 years of postdoctoral experience, including 5+ in a drug discovery setting (biotech or large pharma)
    • Demonstration of scientific leadership and strategic direction
    • Track record of drug discovery project leadership from lead identification through to development candidate stage
    • External recognition of scientific leadership in translational setting
    • Excellent experimental, technical and project leadership skills
    • Preferred experience with due diligence of business development opportunities in drug discovery setting
    • Excellent written and oral communication skills
    • Ability to work productively in a collaborative and cross functional team environment
    • Experience in protein homeostasis research (e.g. ubiquitin / proteasome pathway, heat shock response, protein folding, trafficking and ER stress) is essential.

    ** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.

    Applicants should send a resume and cover letter to: Director of Human Resources at recruiting@proteostasis.com


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    Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Research Associate – Bioprocess Analytics

     

    Codiak Biosciences is seeking an analytical scientist to help develop the company’s novel exosome bioprocessing platform.  Responsibilities will include providing technical/scientific expertise and lab support in all analytical areas related to cell culture, purification, formulation, high throughput technology, PAT and, particularly, exosome characterization.  Strong background in biochemistry and bioanalytics, including all relevant analytical methods will be needed.  Understanding of exosome biology, isolation and characterization will be an advantage.  This is a unique opportunity for a strong analytical scientist to contribute experimentally, as well as intellectually, to both early- and late-stage process development of a novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the lab.

     

    Qualifications

     

    The candidate will have a degree in biochemistry or a similar discipline.  Practical experience with a broad range analytical technologies is expected.  The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments.  Additional qualifications include, excellent interpersonal and presentation skills.

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome technology are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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    Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Research Associate - Purification

     

    Codiak Biosciences is seeking a purification scientist/biochemical engineer to help develop the company’s novel exosome downstream platform.  Responsibilities will include providing technical/scientific expertise and lab support in all downstream areas, such as filtration, centrifugation, various types of chromatography, high throughput technology, virus inactivation, formulation, etc.  Background in biochemistry, bioanalytics and virus purification will be a plus.  Understanding of exosome biology, isolation and characterization will be an additional advantage.  This is a unique opportunity for a strong scientist/biochemical engineer to contribute experimentally, as well as intellectually, to both early- and late-stage development of a novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the lab.

     

    Qualifications

     

    The candidate will have a degree in biochemistry, biochemical engineering or a similar discipline.  The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments.  An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize and flexibly re-prioritize diverse studies is
    invaluable.  Additional qualifications include, excellent interpersonal and presentation skills.

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome technology are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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    Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Cell Culture Scientist/Biochemical Engineer

     

    Codiak Biosciences is seeking a upstream scientist/biochemical engineer to develop the company’s novel cell culture bioprocessing platform.  Responsibilities will include providing technical/scientific expertise and leadership in all upstream areas, such as cell line development, clone selection, cell banking, inoculum expansion, high throughput technology, bioreactor operation, cell characterization, media development, etc.  Background in downstream processing, bioanalytics and cell-based assays, will be a plus.  Understanding of exosome biology, isolation and characterization will be an additional advantage.  This is a unique opportunity for a strong scientist/biochemical engineer to contribute experimentally and intellectually to both early- and late-stage development of Codiak’s novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the lab. The candidate will also play a critical role in helping evolve Codiak’s scientific and business strategy.

     

    Qualifications

     

    The candidate will have a PhD in biology, protein/biochemical engineering, tissue engineering, or a similar discipline, with 5+ years of experience.  The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments.  An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize, and as needed to flexibly re-prioritize, diverse studies is invaluable.  Additional qualifications include excellent interpersonal and presentation skills.

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome technology are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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    OBJECTIVE: 

    • Responsible for short term sales forecast for newly launched product and other related regular and adhoc analyses
    • Provide functional expertise in advanced analytics and drive best practices from the pharmaceutical industry
    • Manage Takeda Recognition Program
    • Lead cross functional team to ensure accuracy and completeness of all aspects of GPO performance based contracts including administration/operations, reporting and analysis

    ACCOUNTABILITIES:

    • Partner with Sales Management and Marketing to identify and support key strategies to drive the brands strategic imperatives, with a strong focus on predictive analytics. Partner with the Sales Training department to develop all training for current and new field based employees on the reporting and analytical tools available.
    • Design a solution combining multiple internal and external datasets that include 3rd party physician and claims databases to provide effective and efficient reporting solutions that are presented in graphical and/or tabular format. Seek and obtain other data sources that will add to the existing data portfolio.  Streamline data feeds from various sources ensuring timely and accurate information for end users.  Solution will result in development of key business insights and actionable recommendations for Sales and Marketing. 
    • Develop robust analytics to provide insight and recommendations on a variety of issues/imperatives impacting brand success. Continuously refine and improve reports and data visualization to support commercial effectiveness and decision-making.  Work closely with senior leadership and field sales management to understand their business reporting, analytics and KPI needs. Collaborate to develop and implement new reports and analyses that meet the evolving needs of the business.
    • Participate on cross functional team that develops the long range revenue forecast.  Responsible for translating into current year forecast with accurate weekly and quarterly information for tracking to actual performance
    • Manage and administer the Takeda recognition program.  This includes vendor management, oversight of the budget and collaboration with HR and Sales management
    • Oversight and ownership of all aspects of GPO performance based contracts.  This includes quarterly roster reconciliation, collaborating with Distribution, IT, Data Steward team, Sales Management and field personnel.  Requires effective communication with GPO partners.  Develop reporting to monitor and track contract performance.  Assist government pricing team with rebates and admin fee calculations.
    • Support business processes including quarterly sales business planning, annual brand planning and other projects with data and insights that inform strategy.


    QualificationsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

    • Bachelors degree required, MBA preferred
    • Minimum 8 years’ experience in pharmaceuticals/relevant industry /commercial environment, with a minimum of 5 years of direct commercial experience.
    • Demonstrated ability to think strategically, identify key issues and value drivers, and translate strategic insights into an appropriate analytic framework
    • Strong analytical background
    • Excellent organizational and problem solving skills
    • Proficiency in a wide range of software applications (i.e. MS word, Excel, PowerPoint, CRM systems etc.)  Advanced Excel skills a must
    • Self starter, must possess leadership capabilities with minimal direct supervision
    • High level of accuracy and attention to detail
    • Ability to manage a large volume and prioritize workload accordingly based on urgent issues
    • Demonstrated proficiency and experience in managing analytically rigorous projects and intiatives

    PHYSICAL DEMANDS:

    • Routine demands of an office based environment.
    TRAVEL REQUIREMENTS:
    • Minimal, 5-10%

    we are driven to improve people's lives

    www.takedajobs.com

    Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx


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    Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Purification Scientist/Biochemical Engineer

     

    Codiak Biosciences is seeking a purification scientist/biochemical engineer to develop the company’s novel exosome downstream platform.  Responsibilities will include providing technical/scientific expertise and leadership in all downstream areas, such as filtration, centrifugation, various types of chromatography, high throughput technology, virus inactivation, formulation, etc.  Background in biochemistry, bioanalytics, virus production and purification will be a plus.  Understanding of exosome biology, isolation and characterization will be an additional advantage.  This is a unique opportunity for a strong scientist/biochemical engineer to contribute experimentally, as well as intellectually, to both early- and late-stage development of a novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the lab. The candidate will also play a critical role in helping shape Codiak’s scientific and business direction.

     

    Qualifications

     

    The candidate will have a PhD in biochemistry, biochemical engineering or a similar disciplines.  The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments.  An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize, and to flexibly re-prioritize, diverse studies is invaluable.  Additional qualifications include, excellent interpersonal and presentation skills.

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome technology are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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  • 01/21/16--01:20: Analytical Scientist
  • Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Analytical Scientist

     

    Codiak Biosciences is seeking an experienced analytical scientist to develop the company’s novel exosome bioprocessing platform.  Responsibilities will include providing technical/scientific expertise and leadership in all analytical areas related to exosome characterization, cell culture, purification technology, formulation, high throughput technology, PAT, etc.  Strong background in biochemistry and bioanalytics, including all relevant analytical methods will be needed.  Understanding of exosome biology, isolation and characterization will be an additional advantage.  This is a unique opportunity for a strong analytical scientist to contribute experimentally, as well as intellectually, to both early- and late-stage process development of a novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the lab. The candidate will also play a critical role in helping shape Codiak’s scientific and business direction.

     

    Qualifications

     

    The candidate will have a PhD in biochemistry or a similar discipline.  Experience with diverse analytical technologies, such as affinity, chromatography, mass spectrometry, cell based assays, etc., is expected.  The successful candidate will have the ability to work well independently, and as part of the growing Codiak team, and be able to quickly design and execute thoughtful experiments.  An aptitude for efficient and dynamic experimental design is critical in early development and the need to prioritize, and to flexibly re-prioritize, diverse studies is invaluable.  Additional qualifications include, excellent interpersonal and presentation skills.

     

    Those interested in contributing to Codiak Biosciences’ development of the nascent and exciting field of exosome technology are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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    GENERAL SUMMARY OF POSITION:

     

    The Research & Development Scientist I is responsible for the design and execution of experiments in chromatography, ultrafiltration/diafiltration, and filtration of immunoglobulin-based therapeutics. The candidate is expected to develop and optimize purification processes, define process parameters, limits, and ranges, and troubleshoot scale-up of the process. The Scientist I is also responsible for associated protein characterization assays to assess product quality throughout the purification process.

     

    For more information please visit our website:

     

    www.MassBiologics.org

    MAJOR RESPONSIBILITIES:

    • Designs, optimizes and characterizes antibody isolation and purification processes. Defines purification procedures and operation specifications. Utilizes techniques such as affinity, ion exchange and HIC chromatographies, and other appropriate unit operations
    • Develops and implements protein characterization assays including HPLC, ELISA, Electrophoresis
    • Ensures that all work is properly documented and suitable for regulatory submission
    • Drafts technical reports to support technology transfer, regulatory and intellectual property submissions
    • Maintains substantial knowledge of state-of-the-art principles in antibody purification, characterization and validation
    • Provides technical guidance and leadership to process development staff
    • May manage process development projects and supervise junior process development personnel
    • Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solution. Normally receives general instructions on routine work, detailed instructions on new assignments
    • Perform additional job related duties as required



    REQUIRED QUALIFICATIONS:

    • Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Chemistry, Biochemistry, or other relevant field and 0-2 years of relevant experience in protein purification and characterization. Experience with protein purification is preferred
    • Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge of scientific principles and concepts
    • Must be detailed orientated with the ability to maintain accurate records and excellent proofreading skills
    • Must have excellent time management and organizational skills, to meet deadlines with minimal supervision
    • Occasional travel is required
    • Willingness to work extended and, at times, unusual hours to meet business needs

    PREFERRED QUALIFICATIONS:

    • Experience with typical column and membrane chromatography, such as affinity, anion/cation exchange, hydrophobic interaction, and/or mixed mode is required
    • Experience with AKTA FPLCs. Knowledgeable in the principles of biochemical and biophysical analytical techniques such as SDS-PAGE, HPLC, western blotting, IEF, ELISA, differential scanning calorimetry (DSC), and dynamic light scattering (DLS) is preferred

    Must be able to carry out the essential functions of this position, with reasonable accommodation if disabled

    PI92741187


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    The Company:

    Flexion Therapeutics (NASDAQ: FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies.

    The company’s lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

    Flexion is based in Burlington, Massachusetts.

    The Role:

    Flexion announced in December that we enrolled our first patient in a PK study of FX006 (Zilretta).  As we continue our growth during this critical period, we are expanding the regulatory team and looking for a Specialist/Sr. Specialist of Regulatory to join our team.  In this role, you will have the opportunity to prepare submissions to FDA and other regulatory authorities, contribute to regulatory strategy development and participate in cross-functional teams in a dynamic environment.

    Osteoarthritis is a painful and debilitating musculoskeletal disease and the incidence is increasing rapidly, expected to affect 45 million Americans by 2030. Current treatment options — including opioids and common anti-inflammatory medicines — are not always effective, and many carry serious risks and side effects.  We are excited to build a team that can make a difference for patients and their families.

    Responsibilities:

    • Participate in the preparation of documentation packages for Regulatory submissions (including IND and amendments, CTA, NDA, etc.) to the FDA, and other Regulatory Agencies.
    • Edit, coordinate and review regulatory documentation for inclusion in regulatory submissions.
    • Coordinate collection of information from other departments (Medical, Clinical Operations, CMC, etc.) for implementation in Regulatory submissions and maintains the established project plan for submission deadlines.
    • Act as Regulatory representative on cross-functional study teams and coordinates international clinical trial applications with CROs, as required.
    • Keep up to date on changes in FDA and other global health authority regulations and guidance documents that may impact Flexion’s development and/or commercial assets.

    Requirements: 

    • 3-5 years Regulatory Affairs experience in Pharmaceutical/Biotech Industry
    • Previous experience in preparing Regulatory submissions for drugs/biologics to the FDA
    • Knowledge and practical understanding of FDA and ICH Guidelines regarding GMP/GCP
    • Excellent oral and written communication skills and time management skills
    • Thorough knowledge of CTD/eCTD format and regulatory submission requirements

    Education:

    BA/BS degree is required.


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    Blue Stream Laboratories, a fast-growing biochemical/analytical CRO, seeks a creative, highly-motivated individual who is ready for an exciting, entrepreneurial workplace, and who wants to contribute to a dynamic, success-driven team.

    The Quality Assurance Documentation Specialist will work to implement and maintain document control procedures of Quality Systems supporting GLP/GMP testing and characterization programs at Blue Stream Laboratories, in compliance with the company policy and applicable industry guidelines and best practices.  This position will perform under the guidance of the head of Quality Assurance Department or designee.

    Primary Responsibilities:

    • Perform essential tasks in documentation control, coordination, and process management for document creation, revision, issuance, archiving, and maintenance of databases.
    • Maintain documentation related to equipment validation, calibration, maintenance, and operation as appropriate to ensure compliance with cGMP.
    • Maintain systems and database for management, tracking, and analysis of non-conformances.
    • Issue and track training documents, maintain training files and database.
    • Conduct and support investigations of non-conformances as appropriate and as required.
    • Perform and support internal audits and external audits, including client and vendor audits.  Assist in audit tracking and maintenance of pertinent documentation.
    • Assist in staff training.
    • Communicate with internal and external clients as required.
    • Support overall compliance with company policy, GLP and GMP regulations, and industry standards as they relate to Blue Stream Laboratories activities.
    • Contribute to the efficiency of Quality System by identifying and suggesting improvements and eliminating non-value added work.
    • Support development and implementation of new initiatives.

    Desired Background and Experience:

    Bachelor’s degree, with 0–5 years of experience in an equivalent role.  Previous experience in regulated environments, especially for pharmaceutical or drug development organizations in activities supporting GMP or GLP functions, is desirable.  Experience with use and implementation of electronic data management systems is beneficial. 

    Professionalism, attention to detail, and organizational skills are essential for this position.  Good communication and interpersonal skills are also required, as the position includes frequent communication with internal and external clients, vendors and suppliers.  The candidate must have an ability to define and establish processes, and propose and implement solutions for increased efficiency.  Familiarity with regulatory guidance documents is highly desirable.

    The individual must be willing to receive a combination of on-the-job and outside training, and must be personally motivated toward increasing level of responsibility. 

    To apply for this position, please email your resume to: vouterbridge@bluestreamlabs.com. Please specify Job Code MBCQADS0121.


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    Primary Duties

    * Leads development and execution of multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
    * Serves as the global expert within Shire in support of the product/disease area incl. the respective charitable strategy
    * Leads the global medical team for the product/disease area
    * Responsible for development and in-year implementation of medical plan in the US and global and oversight of in-year implementation by International Medical Affairs
    * Oversees strategic definition and implementation of in-year plans by International Medical Affairs Develop and management of the Global and US medical budget
    * Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
    * Establishes appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
    * Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between GMA personnel and external stakeholders

    * Responsibilities Definition of global medical strategy and plans

    * Lead development of medical strategies, including in-line R&D LCM, publications, congress, customer interaction, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
    * Develop in-year medical tactical plan and budget for U.S. and global initiatives
    * Lead the Global Medical Team

    * Collaborate with Legal, Compliance and Regulatory and Medical Training to ensure understanding and adherence of global medical team to Shire and external policies and regulations
    * Coordinate with Head of Medical Affairs (Therapeutic Area), Global Medical Team and Global Medical Training to define and address team training and professional development needs related to the product/disease area
    * Oversee and manage in-year implementation of global medical strategy
    * Directly lead (US) and guide (International) implementation of strategy, potentially including:
    * Providing physician leadership for scientific communications, including standard responses and publications
    * Lead the Global Medical Team

    * Collaborate with Legal, Compliance and Regulatory and Medical Training to ensure understanding and adherence of global medical team to Shire and external policies and regulations
    * Coordinate with Head of Medical Affairs, ( Therapeutic Area), Global Medical Team and Global Medical Training to define and address global medical team training and professional development needs and training needs related to the product/disease areaam
    * Interaction with external stakeholders in alignment with customer needs and medical strategy

    * Act as a senior company representative with external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities
    * Establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
    * Maintenance of knowledge base

    * Serve as a key medical resource on the disease area and on specific products
    * Maintain a high level of expertise on the disease area
    * Develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and Shire policies related to all medical activities

    * Education and Experience Requirements
    * A medical degree is required
    * >8 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure.
    * Experience in medical affairs is required
    * Experience leading teams at the brand or disease area levels in country, regional or global organizations is required
    * Experience in field-based roles (e.g. Medical Director, Medical Science Liaison) is preferred
    * Experience in clinical development is preferred
    * Experience in the disease area of interest through clinical experience, biopharmaceutical experience or education is preferred 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=amRpZXR6LjcxNjcwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 01/21/16--23:23: Biostatistician

  • Primary Duties
    * Works with the medical director, the regulatory lead and other clinical operations staff on the project team on clinical development plans; the design and conduct of clinical trials or registry studies; the evaluation, interpretation, and reporting of trial or registry results for publications; and regulatory submissions.
    * Develops appropriate statistical methods for data analysis and ensures the accuracy and reproducibility of data sets and analyses of clinical trial or registry data by following relevant work practices and procedures.
    * May participate on project teams as the lead biostatistician on one or more multi-protocol projects within a therapeutic area.
    * Communicates with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.

    Responsibilities 35%
    * Ensures all statistical work is processed on time to appropriate quality levels
    * Reviews project protocols, authors protocol statistical analysis sections, including sample size calculations or simulations
    * Generates and/or coordinates the creation of randomization schedules and ensures their accuracy
    * Reviews case report forms to ensure that protocol objectives are met and project standards are maintained
    * Develops statistical analysis plans for clinical trials or registry studies with fully documented table, listing, and figure shells.
    * Specifies statistical terms, equations for derived variables and algorithms for analysis
    * Prepares documentation/specifications to support SAS code for analysis programs
    * Understands and has the ability to use advanced statistical methods.

    35%
    * Leads the analysis and reporting of results for clinical trials program or registry database, which may include ISS and ISE, annual reports and/or other regulatory documents.
    * Verifies statistical programs, data sets used and statistical results in regulatory documents and other reports
    * Develops SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays
    * Produces statistical reports as required

    20%
    * Provides statistical interpretation of results and explains statistical methodology to team members
    * Discusses statistical aspects of studies with medical director and regulatory authorities.
    * Liaises with medical writers, interpreting statistical results for input into clinical study reports or other documents
    * Authors and/or reviews results sections of the clinical study report or other reports.
    * Supplies statistical input for regulatory submissions and in response to health authority questions.
    * Provides support for publication of clinical trial or registry database results.

    10%
    * Assists in the Development of SOPs pertaining to Biostatistics and SAS programming, consistent with FDA and ICH regulations and guidelines.
    * Participates in and/or leads process/quality improvement initiatives
    * Provides leadership, quality review, and mentoring to less experienced biostatisticians which may include coordinating the work of other biostatisticians and/or programmers.
    * Helps with the recruitment of biostatisticians
    * Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
    * Presents and discusses the statistical aspects of clinical trials to professional organizations, e.g. FDA reviewers, or less technically oriented audiences.

    Education and Experience Requirements
    * M.S. in Biostatistics or closely related field is required.
    * Ph.D. in Biostatistics or closely related field is preferred.
    * Generally 5+ years of relevant pharmaceutical experience. 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=YWthbmVyLjYyMjU0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0

    Primary Role:
    * Serve as the field-based extension of the Therapeutic Area Medical Strategy Group
    * Systematically identify the scientific exchange needs of Key Opinion Leaders (KOLs), investigators and other stakeholders in patient care, establishing strong professional relationships, providing credible scientific expertise and serving as a liaison to Shire Global Medical, Global Clinical and external partners
    * Ensure compliant communication and education of Shire's marketed and emerging product portfolio to meet the educational and professional needs of Shire's key customers
    * Responds effectively to requests for scientific exchange
    * Support design and implementation of scientific programs with external experts and Global Medical Affairs

    Responsibilities:
    60%: KOL Relationship Management:
    * Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand Shire's research, advisory and educational partnership opportunities
    * Ensures high standard of professionalism to develop and maintain "peer-to-peer" scientific relationships with key thought leaders in healthcare, academia, payer, and government organizations per strategic territory plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
    * Serve as a liaison between HCPs and Shire medical affairs
    * Facilitate 1:1 and group scientific interactions with healthcare professionals
    * Participate in KOL planning

    30%: Effective and Compliant Dissemination of Data
    * Respond within defined timeline and quality standards to unsolicited inquires from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
    * Support development of appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
    * Presents clinical and disease state information to a variety of audiences, including KOLs, Medical advisors, formulary/decision makers and other HCPs
    * Ensures appropriate scientific exchange with HCPs by fostering fair and balanced medical and scientific communications that are not misleading

    5%: Contribute to Shire's Strategic Medical Strategy
    * Provide scientific input and participate into local medical and cross-functional initiatives
    * Provide field-based medical support to Shire's clinical research programs, registries, and facilitation of ISTs
    * Communicates key medical insights from KOLs/HCPs to inform refinement of medical strategy
    * Gains customer insights, opinions and feedback and engages with internal colleagues to connect business opportunities with internal resources
    * Under the guidance of MSL Team Lead or Region Lead, provides scientific support for company-sponsored meetings

    5%: Maintaining personal expertise in relevant disease areas and MSL best practices
    * Maintain knowledge base and scientific expertise on all assigned Shire disease areas and
    products
    * Develop and update knowledge of applicable pharmaceutical guidelines and regulations,
    including, but not limited to, ICH, GCP, PhRMA, DOJ, OIG, R&D code of Ethical Practices
    and company policies
    * Develop/increase knowledge of medical literature and critical appraisal of scientific publications

    Education & Experience Requirements:
    * An advanced degree in life sciences (MD, PharmD or PhD or equivalent) is required
    * Has an established track record of effective and influential oral presentations within the healthcare profession
    * Demonstrative therapeutic research or substantive patient care experience is required (3 years minimum)
    * Demonstration of expertise in key skills and competencies
    * Medical Affairs or Medical Science Liaison experience required

    Other Job Requirements:
    * Frequent travel is required. Availability to travel approximately 40-70% of time
    * Availability to attend meetings on holidays and weekends
    * Clean and valid driver's license

    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=amRpZXR6LjgzODM2LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    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 QC Scientist II will support activities within the Quality Science and Technology group within Quality Control Microbiology. The QC Scientist II will support microbiological validation assays involving commercial in-process cell culture, purification and bulk drug substance 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.
    * Have a working knowledge of and able to perform traditional microbiology testing (bioburden and LAL) in support of commercial product 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.
    * Experience with microorganism handling/preparation and aseptic techniques.
    * 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 participates in the investigation to resolve and correct.
    * Designs assays and experimentation, with guidance, in support of contamination investigations; strong understanding of study design
    * 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. Ensures that technical reports are prepared in a timely manner, and reviews these reports for technical accuracy and compliance.
    * Oversees maintenance of all related records, and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.
    * Highly motivated individual who receives minimal supervision on routine assignments. Demonstrates flexibility and ability to multi-task. Ability to plan and prioritize concurrent assignments/tasks.
    * Capability and desire to work as a team member in a fast paced environment.
    * High level of communication skills with peers and management. Demonstrates a positive attitude.
    * Understands the theory behind the techniques ("hows" and "whys" of what he/she performs) or is willing to learn.
    * Detail oriented; able to compile data in a clear and understandable format and notice discrepancies, calculation errors, and deviations from test methods and/or acceptance criteria

    Qualifications
    * Bachelor's degree in Microbiology or related field with a minimum of 4 years or MS with a minimum of 2 years of industry experience, preferably in the biopharmaceutical industry.
    * Knowledge and practical application of relevant techniques - classical microbiology techniques required
    * Knowledge and practical application of novel rapid microbial technologies (such as PCR) desired but not required
    * Experience with technical writing, such as scientific reports, technical papers, method validation reports, etc. a plus
    * Demonstrated ability to independently document methods and some experience troubleshooting methods
    * Proficiency with Labware LIMS, MS Word and Excel.
    * cGMP experience is required

    PHYSICAL/MENTAL REQUIREMENTS
    * Ability to walk and stand for periods of time
    * Ability to sit for periods of time

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    Monday-Friday, 1st shift

    Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS4wODYzMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


    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 Technical Associate's primary responsibility is to provide basic husbandry, handling, and restraint and health surveillance of laboratory animals in compliance with local regulatory requirements. This individual will also provide daily record keeping of common laboratory species, their environments, and provide basic technical assistance (i.e., restraint, injections, bleeds) to other technicians and researchers. Other more specialized functions, depending on interest and aptitude may be assigned in the areas of technical and research services.

    Responsibilities
    * Support research by providing basic rodent technical services (restraint, dose administration, and blood and tissue collection) to research investigators.
    * Proficiency in rodent dosing routes such as PO, SQ, IP, and IV preferred.
    * Proficiency in rodent blood and tissue collection preferred.
    * Expertise in routine animal husbandry and welfare duties as directed.
    * PC knowledge such as Excel, Share Point, MS windows based applications email, online forms, web-based training and other basic programs preferred.
    * Required to work with all rodent strains across the site with assignments based on the business needs.
    * Supply appropriate food and water for animals housed in the vivarium.
    * Clean and provide animal housing and associated materials/equipment within assigned animal rooms.
    * Observe and report status of animal health, food and water consumption, appearance, behavior; provide support in animal health monitoring and basic veterinary medical treatment as prescribed by the veterinary staff.
    * Observe and record vivarium environmental conditions.
    * Perform sanitation duties within assigned animal rooms and vivarium areas.
    * Maintain and perform housekeeping of facility support areas.
    * Support and Operate cage wash equipment operations and maintenance.
    * Adhere to Pfizer and departmental safety policies and departmental SOPs and guidelines while demonstrating competency in facility safety protocols.
    * Establish and maintain appropriate and quality communication, teamwork, collaboration, and cooperation.

    Qualifications
    Educational Background:

    High school degree or GED required; Associates or BS/BA in related field preferred
    AALAS certification at the ALAT level preferred

    PHYSICAL/MENTAL REQUIREMENTS
    * Experience working in a laboratory animal setting required.
    * Ability to demonstrate level of technical skills and abilities.
    * Must be able to lift 50 pounds and work standing up lifting items above shoulder level for extended periods of time.
    * Ability to perform repetitive physical activities such as: pushing and pulling racks of caging, lifting bags of feed and bedding, reaching, stooping and bending. A Functional Capacity Evaluation may be required.
    * Weekend and holiday work are required for the job.
    * Experience working in a pharmaceutical setting preferred.
    * In general, a colleague at this level will have 1 year of experience.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    Successful candidates must be able to work Saturdays and Sundays routinely as part of their schedule.

    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=SmFtZXMuQ3JvbmluLjA5NzQwLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


    0 0
  • 01/21/16--23:35: Non MD Clinician, Director

  • 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
    Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to develop innovative therapies that significantly improve the lives of patients. A career at Pfizer offers opportunity for both individual and company success, and to be part of an ownership culture that values diversity and contributes to positively impacting the health and lives of millions of people.

    The non-physician Clinician is responsible for working collaboratively with the clinical leader and members of the development team to develop clinical plans for one or more compounds from lead development to Phase 1-2 clinical trials. The incumbent will actively participate in writing clinical protocols.

    Responsibilities
    * Assist in formulating clinical development plans.
    * Assist in writing protocols, amendments and conducting data review, analyses and interpretation.
    * Conduct regular reviews of subject safety data and perform reviews of cumulative safety data in collaboration with the safety risk lead.
    * In conjunction with the clinical lead, prepare strategy presentations, present and discuss data at relevant team, governance, and external consultant, meetings.
    * Author clinical sections of regulatory documents (IB, Annual Reports, IND sections).
    * Routinely collaborate with discovery scientists, clinical pharmacology, safety sciences, statistics, regulatory, development operations and other members of the extended project team(s).

    Qualifications
    * Graduate degree in the life sciences and breadth of knowledge and experience in clinical research in an industry or academic setting.
    * 5-7 years directly related experience in clinical research in an industry or academic setting.
    * Familiarity with related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
    * Demonstrated writing skills (regulatory documents, publications, etc.).
    * Proven scientific writing skills and good communication skills.
    * Previous experience working in a similar role.

    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=TWVnYW4uSGFycmlnYW4uOTE4NzAuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t


    0 0
  • 01/22/16--00:46: Postdoctoral Associate
  • About us:
    Our lab’s mission is to uncover biological knowledge by developing advanced methods to quantify and mine the rich information present in images.  We love working as a team towards scientific goals: discovering the inner workings of biological systems and influencing patient treatment.  We love making open-source software that impacts the world.  We are conscientious and enjoy a professional environment.  

    This is an opportunity to make important contributions through many different individual projects as well as by supporting thousands of researchers around the world who are accomplishing great things with our lab’s open-source software, CellProfiler.  CellProfiler is launched 130,000+ times per year around the world by scientists quantifying biological processes in images.  Cited in more than 3,000 scientific papers, it has led to potential therapeutics related to the Ebola virus, tuberculosis, AMKL, leukemic stem cells, and CCM.

    Responsibilities:-
    Deep impact, on important biomedical research projects: Develop image analysis pipelines using CellProfiler, working in-depth with brilliant biomedical researchers to push forward the boundaries of what can be extracted from high-throughput imaging experiments.  We collaborate with dozens of biomedical research laboratories to identify disease states, potential therapeutics, and gene functions from microscopy images.

    Broad impact, supporting the CellProfiler community:
    - Support thousands of CellProfiler users worldwide by answering questions at our popular online forum. Deliver educational workshops on image analysis and the usage of CellProfiler (including traveling 5+ days/year).

    Grow:
    - Opportunity for advancement, taking on administration and management of the team’s many projects.  B. S.  in science (PhD not required, although postdoctoral candidates will be considered) Strong understanding of biology  Significant experience using image processing software on biological assays  

    A personality that is helpful, professional, highly organized, and goal-oriented, efficiently juggling projects and competing demands

    Able to clearly communicate with biology collaborators about project aims and results, and with software engineers on the team about image processing and software needs

    Preferred but not required:

    - CellProfiler expertise, programming experience (Python - though we are not looking for a computer scientist to develop novel computational algorithms from scratch), and experience with Linux environments, databases, computing clusters, and bioinformatics/statistics tools (e. g. , R).

    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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