Senior Scientist, CMC
Ansun Biopharma is a clinical stage biotherapeutic company focused on the discovery and development of broadly applicable, immunomodulating therapies including cell/gene therapy, recombinant protein and antibodies to treat cancer and respiratory diseases. Our lead product, DAS181, is a multi-mechanism sialidase fusion protein designed to save the lives of vulnerable patients suffering from severe respiratory infections. Ansun aims to further develop DAS181, while simultaneously developing and/or acquiring additional assets to build a robust pipeline of infectious disease and oncology candidates.
Ansun has an exciting opportunity for a highly motivated individual to fill a Senior Scientist position in the CMC organization in San Diego, CA. The upstream cell culture division of the CMC organization is responsible for all aspects of the upstream cell culture development required to progress biologics candidates from discovery into and through clinical development stages. In this lab-based role, the candidate will utilize knowledge and experience of cell culture process development for traditional biologics such as recombinant proteins and advanced therapeutics such as cells and oncolytic virus therapies, to develop Ansun’s pipeline products (NK and CAR NK therapies, oncolytic virus and bispecific antibodies). The candidate will develop innovative cell culture solution to produce various advanced therapeutic modalities with high titer and quality.
- Accountable for the development, characterization, optimization and transfer of robust and high quality upstream cell culture process to support Drug Substance and Drug Product for research, preclinical and clinical use.
- Accountable for the management of contracted cell culture process to meet the needs for quality, compliance and business imperatives including tracking, submitting reports and supporting data.
- Organizes and prepares upstream cell culture components of CMC regulatory filings including descriptions of the process, process control, batch record and raw materials.
- Provide responsive, timely and high quality production of materials for research and downstream and analytical/formulation development needs.
- Ensure cell culture instruments are operating correctly with minimal downtime with good use practices, routine maintenance, troubleshooting problems and obtaining outside service.
- Any other duties as assigned
- BS and above in biology, chemical or biochemical engineering or related discipline.
- Degree and relevant pharmaceutical/biotechnology development experience: 3 years with Ph.D., 6 years with MA, 8 years with BS. Position and title will be based on degree and total years of relevant experience in industry and academia.
- Familiarity with ICH guidelines and other regulatory and quality standards.
- Experience in molecular and cell biology, engineering and statistics as part of the cell culture process development required. Viral vector and cell therapy (such as NK, CAR-NK, CAR-T) production and GMP experience highly desirable. Hands-on development and troubleshooting experience with various bioreactor and large scale bioproduction are required.
- Must have strong written and verbal communications skills.
- Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.
- Must be hands on in the lab, well organized, detail orientated and collaborative.
- Special Working Conditions: Exposure to hazards or disagreeable conditions such as organic solvents, glassware under vacuum, laboratory machinery such as pumps, centrifuges, etc.
- Working with potentially toxic or pharmaceutically active biological and chemical entities.
- Special physical or visual requirements: Lifting containers containing up to 5 gallons of solvent.
- Travel: about 5%
- Employee Incentive Stock Options
- Medical, Dental, & Vision Coverage
- Paid Vacation & Sick Time
- Life & Disability Insurances
- 401(k) Retirement plan
- Flexible Spending Account (FSA)
Ansun Biopharma is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.
We are committed to providing reasonable accommodations, if you need an accommodation to complete the application process, please contact HR; 858-452-2631.