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Astellas Pharma QC Associate II, Analytical in Westborough, Massachusetts

AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Analytical Associate II . This position provides Quality Control compliance, commercial readiness, and testing support for AIRM cell therapy products. Looking for a strong GMP and scientific background and experience with quality control testing of cell-based therapies.

Essential Job Responsibilities:

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

  • Execute GMP analytical assays such as Immunofluorescence, Flow Cytometry, PCR, Viability, Cell growth and various parenteral assays (Visual Appearance, Content Uniformity, pH, Osmolality).

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

  • Maintain, calibrate and operate GMP equipment and instruments supporting QC testing.

  • Track and test products according to stability protocols.

  • Culture and maintenance of cell lines and stem cells.

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

  • Monitor and trend QC data.

  • 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. Assist 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.

· Bachelor’s degree in biotechnology or related field with 3+ years of Quality Control experience, or a master’s degree in biotechnology or related field with 0-2 years of Quality Control experience.

  • 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 the qualification 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, national holidays, two 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

Category GMP Technical Operations

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

EOE including Disability/Protected Veterans

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