CONTRACT: 9-month extendable
MUST HAVES:
- Bachelor's degree in life sciences, engineering, or related discipline required
- Minimum 3 years of biopharmaceutical industry experience with QC method transfer/method qualification activities and performing analytical methods such as qPCR and ELISA
Overview
We are seeking a highly motivated and experienced Quality Control Analyst I/II to join our Quality Control team. You will be responsible for day-to-day activities in the quality control laboratories.
This role will play a key part in supporting the analytical method feasibility, method transfer and qualification for NKSTIM, Drug Product Vector virus.
Key Responsibilities
- Assist in method knowledge transfer, method feasibility studies, method qualifications and method transfer, including but not limited to protocol drafting, execution, data review and report drafting.
- Perform product testing (in-process, release, stability) most assays are cell-based (e.g., thawing of cells, cell counting, flow cytometry, PCR, etc.)
- Review executed QC test records for product release, in-process, stability, training, and/or qualifications.
- Review equipment logbooks, inventory logs, reagent preparations, etc.
- Perform weekly, monthly, quarterly maintenance on QC equipment (e.g. waterbaths, BSCs, incubators, etc.)
- Support authoring and revision of laboratory procedures.
- Support authoring/review of quality systems records such as deviations, change controls, CAPAs as required.
- Additional duties may be assigned.
Position Requirements
- Bachelor’s degree in biology, Chemistry, Life Science, or Engineering is required.
- 3+ years of direct experience in Analytical Development and GMP QC is required. Experience with cell therapy, qPCR and ELISA is preferred.
- Previous experience reviewing data for GDP/GMP compliance as well as audit trail review.
- Excellent communication skills, both written and oral.
- This role will focus lab work with some data review expected. (70% lab + 30% review). Subject to change.
Qualifications
- Bachelor's degree in life sciences, engineering, or related discipline required; advanced degree preferred.
- Minimum 3 years of pharmaceutical industry experience in GxP-regulated environments, with significant time in biologics, cell therapy, or advanced therapies preferred.
Proven experience in:
- Method transfer/method qualification
- Perform analytical methods such as qPRC, ELISA and Cell-based assay
- Review data for GDP/GMP compliance as well as audit trail review.
- Knowledge of GMP regulations
- Comfortably working in a dynamic, fast-paced, and evolving biotech environment.
Education/Background
- Bachelors or higher degree in Biology, Chemistry, Life Science.
- +3 years of biopharmaceutical industry experience.
