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.
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
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