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