Senior Quality Control Analyst

About the position

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. We are seeking a Senior Quality Control Analyst to support our Global Quality Control team. This candidate will execute bio-analytical, cell-based, and/or molecular methods for product release and stability in the Quality Control laboratory. This role will also actively participate in method transfer, qualification and validation activities.

Responsibilities

• Conduct routine and non-routine testing on products and materials to verify compliance with established standards.
• Manage purchasing, receiving, formulating, testing, release of materials and reagents, equipment and assay qualifications and validation in collaboration with team members.
• Lead quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.
• Author and conduct periodic review of procedures.
• Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures.
• Maintain data integrity and logs for equipment.
• Analyze complex data sets and interpret results accurately.
• Perform and oversee the maintenance and calibration of laboratory equipment.
• Involved in the creation of systems used in quality control to maintain compliance with regulations.
• Demonstrate good safety practices and promote safety awareness.

Requirements

• BA or BS in any science-related field.
• Minimum five (5) years experience in a regulated laboratory environment.
• Experience as a QC personnel in a related field.
• Experience in aseptic technique, cell culture and either flow cytometry or cell-based assays.

Nice-to-haves

• MS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering.
• Demonstrate technical competence and knowledge in method transfer and assay qualification/validation activities.
• Excellent technical writing and troubleshooting/investigational skills.
• Demonstrate knowledge of cGMP/ICH/EU regulations and requirements.
• Experience writing GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.
• Experience with LIMS and statistical software.

Benefits

• Competitive rates for Health, Dental, and Vision Insurance.
• 4 weeks of Paid Time off, granted up front each year.
• Sick Time Off - 56 hours.
• 12 Paid Holidays.
• 100% Employer-Paid Life Insurance up to 1x annual salary, up to 100K.
• 100% Employer Paid Short- and Long-Term Disability Coverage.
• 401(k) with Immediate Eligibility & company match.
• Partially paid Parental Leave for eligible employees.
• Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness.