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Job type: Contract

Discipline: Molecular Biology

Location: United States

Senior Associate Scientist: QC- Contract - Cranbury, NJ

��Ƶ 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:

40-45 USD per hour

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

��Ƶ is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

��Ƶ Staffing is an equal opportunity employer.