Supervisor, Quality Control Analytical - United States
Want to know company name or location? Company managed [?]
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as Supervisor, QC Analytical in our new commercial cell therapy production center.
- You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This role will be a hands-on resource reporting to the Manager, QC Analytical.
- In this role you will be responsible for the day to day oversight of the QC Analytical team. You may be responsible for maintaining the stability program, raw material testing, final product testing and sample management program.
- Supervision of all QC Analytical laboratory testing
- Supervision of sample receipt, retain storage and disposal
- Management of QC Analytical training program
- Work with QC raw materials team to establish specifications and testing process of raw materials.
- Monitor and trend data
- Assemble reports on invalid assay trends. Frequently update management on trends. Implement corrective action plans when necessary
- Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Generation of CoAs for product release
- Develop, revise, and review SOPs, qualification/validation protocols and reports
- Conduct investigations regarding out of specifications (OOS) results, trends in invalid assay and address and manage deviations related to QC Analytical procedures
- Provide updates at daily and weekly meetings
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Gather metric information for use in continuous improvement of areas of responsibility
- Other duties as assigned
- Bachelor's degree or advanced degree in Biotechnology, Biological Sciences or related discipline
- Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
- A minimum of 7 years’ experience working in Quality Control or bio pharma laboratories.
- A minimum of 3 years’ experience supervising/managing analytical biology labs within the biotechnology or pharmaceutical industry
- The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bio-assays and other applicable methods to the testing of bio pharmaceuticals.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Quality Control, GMPs, method development and validation
- Strong knowledge of GMP, SOPs and quality control processes
- Strong data integrity knowledge and practices.
- Identifying, writing, evaluating and closing OOS’s and investigations
- Equipment and utility IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Work schedule will routinely include weekend and evening shift work.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.