Quality Control Associate II

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc 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.

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 Massachusetts.

Astellas is announcing a Quality Control Associate II opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Associate II. This position provides Quality Control qualification, validation, testing support for AIRM cell therapy products. Looking for strong GMP background with method validation and quality control testing experience.

Essential Job Responsibilities:

  • Perform routine in-process and release QC testing of AIRM cell products.

  • Execute analytical method qualifications, validations and transfers including drafting technical protocols, reports, and troubleshooting.

  • Maintain, calibrate, and operate equipment and instruments supporting Immunofluorescence, Flow Cytometry, and PCR assays.

  • Track and test products according to stability protocols.

  • Work with internal and external resources to maintain lab in a GMP state

  • Monitor and trend QC data.

  • Support validation and testing of cell bank programs.

  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability.

  • Perform shipment of materials for QC testing to contract labs and perform data review.

  • Author, revise and review SOPs, qualification/validation protocols and reports.

  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations and CAPAs related to analytical procedures.

  • Monitor the GMP systems currently in place to ensure compliance with documented policies.

  • Perform QC lab duties and technical projects as required.

Quantitative Dimensions:

This position interacts with QC, AD, DPD, Mfg and QA management. Will contribute to the development of QC departmental processes.

Organizational Context:

Reporting to QC Analytical Associate Director.

Qualifications:

Required:

  • Bachelor’s Degree / Master’s Degree with 3+ years Quality Control experience in biotechnology, biology or related field.

  • Relevant GMP experience in the quality control department of a biotech and/or pharmaceutical industry.

  • Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.

Preferred:

  • Experience with relevant analytical test methods: including PCR, Flow Cytometry, IFA and cell based assays

  • Experience with ICH guidelines and parenteral test methods

  • Experience with 21CFR Part 11 Compliance

  • Experience with Validation of Analytical Test Methods

  • GMP Cell Culture experience and Environmental Monitoring

  • Experience with JMP software and data tracking/trending analysis

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

#LI-LK

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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