Scientist Upstream Process Development
2 days ago
**Job Description**:
- Perform plasmid cloning, transformation, amplification, and purification.
- Maintain mammalian cell cultures using aseptic techniques.
- Set-up and operate benchtop and large-scale single use bioreactors (50 to 100L)
- Utilize DoE methodology to optimize cell growth and viral vector titers in suspension mammalian cell cultures.
- Collaborate with team members to identify and evaluate process improvements with the goal of optimizing the current rAAV production process.
- Perform molecular biology and analytical assays to support the upstream and downstream PD efforts.
- Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and batch records for regulatory or tech transfer purposes.
- Search literature for methods, processes, and assess new equipment and technologies in order to expand and improve upstream AAV capabilities.
- Work with senior team members to perform and understand process experiments and characterization studies.
**Requirements**:
- Master or Bachelor’s degree with ~6 years or more relevant industry experience in Cell and Molecular Biology, Biomedical engineering, Biochemistry, Biotechnology, Chemical Engineering or related fields.
- Considerable direct experience with mammalian cell expression technology and media optimization, utilizing suspension-based bioreactor systems is required.
- Prior experience in viral vector GMP manufacturing, process characterization and QA/QC release testing of viral vector products are required.
- Experience working in a BSL-2 environment and using aseptic techniques.
- Hands-on experience with bench-scale bioreactor operations and large-scale single use bioreactors (50 to 100L) are required.
- Proficient in general molecular biology techniques such as SDS-PAGE, Western blot, flow cytometry, ELISA, ddPCR, qPCR, PCR and cell-based potency assays.
- Experience in drafting study plans, technical reports, and protocols.
- A highly motivated team player with an ability to be productive and a willingness to learn in a fluid, fast-paced and environment are essential.
- Excellent organizational and collaborative skills, with the ability to design and troubleshoot experiments with mínimal supervision or as part of a group.
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