Analytical Development Scientist
Job Title: Analytical Development Scientist
Location: San Diego
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.
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.
Responsibilities to include:
- Conduct analytical method development for release and stability-indicating assays of new gene transfer candidates.
- Develop, optimize, and qualify key release ATMs for technology transfer and GMP testing.
- Perform forced-degradation experiments to determine key stability-indicating assays.
- Perform secondary analytical characterization on test articles to increase product quality knowledge.
- Develop reference standards and qualification criteria for new product candidates.
- Develop and execute leading stability protocols from engineering batches and other non-GMP materials.
- Perform non-GMP QC testing to support process development
- 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.
Qualifications and Skills
- M.S./ Ph.D. in relevant field with a minimum of 1-2 years related industry experience; Expert knowledge of scientific principles and concepts;
- Required experience in analytical techniques, including immunological (FACS, ELISA), protein (SDS-PAGE), molecular biology (qPCR, agarose gel) and cell-based potency assays;
- Experience in product formulation DoE a plus;
- Must have experience of statistical data analysis;
- Strong analytical, technical writing, communication and data management skills are required;
- Must have the ability to work independently, and multi-task under aggressive timelines to support department and corporate goals.
- Working knowledge of Quality Assurance and Quality Control in a biosafety-contained biologics production setting preferred;
- Strong work ethic, able to adapt to changing priorities in a challenging and fast-paced environment, and capable of working independently and in a collaborative environment;
- Excellent communication and presentation skills (oral and written); Mandarin as a second language a plus.