QC Cell Therapy Scientist - Contract - Cranbury, NJ
Proclinical is on the hunt for a bold, innovative thinker who is ready to help push the boundaries of science and make a tangible difference in the world.
Primary Responsibilities:
The successful candidate will be required to support the clinical and commercial manufacturing of gene therapy products. This role focuses on AAV and LVV gene therapies, requiring strong technical expertise in CGT analytical methodologies and excellent communication and collaboration skills.
Skills & Requirements:
- Background in Biology, Molecular Biology, or Immunology.
- Experience in QC/GMP environments, preferably with gene/cell therapy products.
- Understanding of cGMPs and international regulations.
- Proficiency in cell and gene therapy assays and analytical characterization of viral vectors.
- Experience with mammalian cell culture and related activities.
- Ability to create, revise, and approve SOPs and reports.
- Experience in authoring and approving investigations for IA, OOS, and OOT results.
- Knowledge of method transfer, qualification, and validation.
- Strong analytical and problem-solving skills.
- Ability to work independently and make decisions.
- Effective in a fast-paced environment with a proactive attitude.
The QC Cell Therapy Scientist's responsibilities will be:
- Conduct laboratory techniques such as q-PCR, ddPCR, ELISAs, Western Blot, and Infectivity assays in compliance with cGMPs.
- Perform routine testing for sample release and stability, ensuring timely reporting.
- Manage stability data mining and prepare data summaries.
- Review QC stability data and generate Certificates of Compliance.
- Execute laboratory protocols and prepare reports.
- Sub-culture mammalian cell lines and perform cell counts.
- Maintain laboratory reagents, supplies, and equipment.
- Qualify reagents, reference materials, and analytical techniques.
- Assist in planning and executing stability studies.
- Perform QC data review and generate CoAs for product release.
- Enhance knowledge of analytical techniques and procedures.
- Liaise with functional groups to progress projects and plans.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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