Astellas Pharma Quality Control Scientist in Marlborough, Massachusetts

The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.

Purpose & Scope:

AIRM is seeking a highly motivated individual to join us as a Quality Control Scientist. This position provides Quality Control testing of in process and final product testing. Looking for experience with cell culture, RT-qPCR, Immunofluorescence, Flow Cytometry and cell based assays.

Essential Job Responsibilities:

  • Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays
  • Track and test products according to stability protocols.
  • Work with internal and external resources to maintain lab in an optimal state.
  • Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
  • Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates to Assoc. Director of Quality Control as needed.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Perform other duties as required.

Qualifications:

Required

  • Bachelor or Master's degree in biotechnology or related field with 4 -- 5 years of Quality Control experience or PhD molecular biologist or biochemist preferred with 1-2 years of Quality Control experience.
  • Strong knowledge of GMP, SOP's and quality control process
  • Identifying, writing, evaluating and closing laboratory (OOS) investigations.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • Experience in the biotech and/or pharmaceutical industry.
  • While most of the schedule will be during a standard work-week, there will be occasional weekend work required.

Preferred

  • Experience in the biotech and/or pharmaceutical industry.
  • Ability to work weekends if required.

Disclaimer:

The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Quality Assurance/Quality Control