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 equivalentRelevant experience in QC or equivalent experience in the biotechnology industryPreferred experience with Gene/Cell therapy products for clinical and commercial useExcellent organizational skillsAbility to work independently with excellent problem-solving skillsThorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processingExperience in AAV, and Lenti Viral Vector for gene therapy is highly preferredAbility to interact across departments and functions

The Senior Associate Scientist: QC's responsibilities will be:

Execute assays using HPLC and CE-SDSOperate q-PCR/ddPCR, Capillary ElectrophoresisConduct routine testing of vectors and raw materials for release and stabilitySupport analytical and process development activitiesAssist in general QC labs operations and functionsDocument test execution in compliance with cGMP, maintain up-to-date QC records, logbooks, and notebooksReview protocols, data summaries, reports for stability studies and validationAssist 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

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.