Senior Associate Scientist: QC- Contract - Cranbury, NJ
Proclinical is seeking a dedicated and technically proficient Senior Associate Scientist for Quality Control.
Primary Responsibilities:
The successful candidate will play a crucial role in supporting clinical manufacturing of a variety of Gene Therapy products. This role requires a deep understanding of analytical methodology for gene-based drug substances and products.
Skills & Requirements:
- Degree in Biology, Molecular Biology, Virology, Life Sciences or equivalent
- Relevant experience in QC or equivalent experience in the biotechnology industry
- Preferred experience with Gene/Cell therapy products for clinical and commercial use
- Excellent organizational skills
- Ability to work independently with excellent problem-solving skills
- Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
- Experience in AAV, and Lenti Viral Vector for gene therapy is highly preferred
- Ability to interact across departments and functions
The Senior Associate Scientist: QC's responsibilities will be:
- Execute assays using HPLC and CE-SDS
- Operate q-PCR/ddPCR, Capillary Electrophoresis
- Conduct routine testing of vectors and raw materials for release and stability
- Support analytical and process development activities
- Assist in general QC labs operations and functions
- Document test execution in compliance with cGMP, maintain up-to-date QC records, logbooks, and notebooks
- Review protocols, data summaries, reports for stability studies and validation
- Assist with deviation, lab investigations, CAPA and Change Control
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at
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.