Senior Scientist, Analytical Development
Location: San Diego, CA
Working in our new San Diego facility, the candidate will be responsible for the development, qualification and implementation of new analytical methods for lentivirus from characterization, stability, and product release
Why Join Us?
F1 Oncology is a clinical-stage biotechnology company committed to bringing to market CAR-T therapies for the treatment of cancer. Founded in 2015, The company has rapidly built its core technologies and a growing global presence with operations in China (Shanghai and Shenzhen), Grand Cayman, and across the US with sites in West Palm Beach and San Diego.
This is a full-time position working with a great team and with excellent benefits including company sponsored medical, dental, vision, life insurance, paid holidays and time off, and a 401K match.
Some of the responsibilities:
- Lead the development of new analytical assays for biochemical and biophysical characterization of lentiviral vectors, plasmids, and residual impurity analysis
- Perform non-GMP QC testing to support process development activities encompassing early and late stage viral vector manufacturing
- Perform forced-degradation experiments to identify key stability-indicating assays
- Oversee stability program testing current and future products
- Perform secondary analytical characterization on test articles to increase product quality knowledge
- Create and review technical documents including analytical method development reports, method qualification protocols and reports, SOPs in compliance with regulatory requirements
- Collaborate with other process development groups, and actively support testing of new entities at various stages of development
- May coordinate the activities of external research laboratories that have been contracted to conduct assay development or sample testing
- May participate in technical transfer of assays to GxP testing facilities
- Support the organization in maintaining a work environment focused on quality and that fosters open communication, collaboration, integration, and teamwork
- Aid in the authoring of Regulatory CMC documents and stability trending analysis
- Other duties as required commensurate with the candidate’s background and skillset
We are looking for candidates with this background and education:
- M.S./ Ph.D. in relevant field with a minimum of 4 years related industry experience; expert knowledge of scientific principles and concepts
- Required experience in analytical techniques, including biochemical (FACS, ELISA, SDS-PAGE), molecular biology (qPCR, agarose gel) and cell-based potency assays; biophysical assays a plus.
- Prior experience of working on characterization of either lentiviral vectors, viral based products, or vaccines is a plus
- Working knowledge of Quality Assurance and Quality Control in a biosafety-contained biologics production setting preferred
- Strong analytical, technical writing, communication and data management skills are required
- Must have experience in statistical data analysis
- Excellent communication and presentation skills (oral and written); Mandarin as a second language a plus
- Experience in product formulation DoE a plus
To apply or obtain additional information, contact: email@example.com