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.
Quantitative Dimensions: This position interacts with Quality Control, Analytical Development, Drug Product Development, Manufacturing and Quality Assurance. Will contribute to the development of QC departmental processes.
Qualifications:
Required
Bachelors degree in biotechnology or related field with 3+ years of Quality Control experience, or a Masters 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
