Astellas - (Contractor) - Westborough, MA
posted 3 months ago
Full-time - Mid Level
Westborough, MA
About the position
The Quality Control Associate II, Analytical position at Astellas Institute for Regenerative Medicine (AIRM) in Westborough, MA, is designed for a motivated individual with a strong background in GMP and quality control testing of cell-based therapies. This role focuses on ensuring compliance, commercial readiness, and testing support for AIRM's cell therapy products, contributing to the development of innovative therapies for patients.
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.
- 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.
Requirements
- 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.
Nice-to-haves
- 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 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
