Overview

The incumbent will direct quality control assay qualification, validation and transfer activities to support growth of company's Cell Therapy Center assays for both analytical and microbiological testing. The quality control analytical programs include in-process and final drug product analytical assays such as potency and flow cytometry. The quality control microbiology programs include in-process and final drug product microbial assays such as endotoxin, mycoplasma, gram stain, environmental monitoring, and sterility techniques. Other responsibilities will include supporting capacity studies, training, reagent qualification, comparability studies, and clinical testing. To be successful in this role, you will have strong leadership and substantial experience lading quality control teams in a Pharmaceutical or Biotechnology environment. This position works across different shifts. Depending on your assigned shift, you may be required to work weekends and holidays to complete assigned work.

Essential Functions and Responsibilities

• Direct the QC assay technical team through performance, technical writing, and review of assay transfers, validations, and qualifications with a focus in both analytical and microbiology testing activities.
• Collaborate effectively with Development and ASAT teams to perform assay co-qualification, validation, and technical transfer of updated and new assays, as well as potential new products.
• Collaborate effectively with Development and ASAT teams to perform assay co-comparability and PPQ work.
• Provide training support for the QC analytical and microbiological teams.
• Ensure all technical testing is performed according to company procedures and cGMP.
• Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures.
• Support reagent qualification for analytical and microbiological methods.
• Support testing needs for capacity studies.
• Support clinical and commercial testing as needed.
• Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.
• Support problem-solving during testing and for unexpected test results, working collaboratively with analysts and management as needed.
• Ensure that QC staff are adequately trained, perform tests per method procedures, and consistently implement the required techniques.
• Initiate, revise, and approve site-related analytical and microbiological procedures. Ensure all procedures reflect current operations. Serve as a document reviewer, owner, or approver as appropriate.
• Participate in preparing CMC regulatory submissions and associated Health Authority interactions (e.g., IND, BLA submissions).
• Support the QC function interface during facility tours and pre-approval inspections.
• Accurately interpret and discuss all laboratory-related data within cross functional teams and with health authorities.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum 12 years of experience in the pharmaceutical industry within a Quality Control role
• Quality Control laboratory management experience, including management of direct reports.
• Broad knowledge of quality control for biologics with experience in a leadership role
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Flexible and adaptable style with an eagerness to take on challenges.
• Problem solver who identifies issues and leads efforts to resolve them

Preferred Education, Skills, and Knowledge

• Advanced degree (MSc. preferred.)
• Experience with both analytical and microbiological assays is preferred
• Experience with cell therapy products is a plus.