Search Jobs
View open opportunities and apply.
Quality Control Manager, CAR-T
Raritan, NJ 08869 US
Job Description
QC Manager for one of the Most Admired Companies In The World! Must have Cellular or Genetic Therapy QC / Lab Management experience! Relocation possible. Some of the best benefits in the industry. Join a rapidly expanding CAR-T facility!
The QC CAR-T Manager is responsible for day-to-day Quality Control activities oversight for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures.
Key Responsibilities:
- Manage Supervisors and provide operational guidance to scheduling activities.
- Contribute to global strategies related to QC laboratories which align with compliance and business objects as well as the overall company vision.
- Manage departmental budget and resources; prepares staffing plans.
- Adjust roles and responsibilities of department to meet business needs.
- Provide expertise in troubleshooting complex laboratory issues and demonstrate strong reasoning skills in support of ongoing laboratory investigations.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, and Maintenance to support business needs.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
- Ensure adherence in support Drug Product release testing cycle times.
- Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards.
- Review/approve documents as a QC department subject matter expert (SME).
- Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs, and change controls.
- Ensure accuracy and completeness of executed analytical method transfer activities.
- Communicate department objectives and metrics to staff.
- Support internal and Health Authority audits and inspections.
Â
Education:
- Minimum of a Bachelor’s or equivalent University degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, or related scientific field is preferred
Experience and Skills:
Required:
- Minimum 8 years of relevant work experience
- Experience leading, coaching, or supervising direct or indirect personnel or teams
- Experience in Cell and/or Gene therapy or Biologics
- Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Document Practices (GDP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
Preferred:
- Knowledge and experience in CAR-T cell therapy, T cell biology, and/or immunology
- Experience with LIMs and SAP or equivalent systems
- Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and/or 610
- Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing
Other:
- Requires flexibility to provide occasional support on the weekends or weeknights as needed
- Requires ability to occasionally lift up to 20 pounds
- Requires up to 5% of domestic travel
Â
The anticipated base pay range for this position is $97,000 to $166,750.
Meet Your Recruiter
Sean Goulding
Vice President – Technical Recruiting, Skilled Labor, Accounting And Finance
Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.