Process Engineer (Downstream)
Job Title: Process Engineer (Downstream)
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 and scale-up of new lentiviral downstream purification processes from pilot to cGMP manufacturing.
Responsibilities to include:
- Assist in the development and implementation of scalable downstream purification processes;
- Establish state-of-the-art scale (small-scale) downstream models and capabilities for screening;
- Perform hands-on execution of process development DoE and projects using a wide application of experience across chromatographic theory, virology and biotechnology;
- Work collaboratively with Upstream PD, Analytics and Research groups to develop an increased depth of knowledge of product characteristics and identify improvement opportunities;
- Perform technical writing, including SOPs, BPRs, data interpretation, presentation, statistical analysis and trending;
- Participate in decision-making within the project team by actively engaging in scientific and technical discussions;
- Resolve technical challenges through root cause analysis, scale-down modeling and application of innovative solutions;
- Aid in the authoring of regulatory CMC documents;
- Other duties as required commensurate with the candidate’s background and skillset.
Qualifications and Skills
- Ph.D. in biochemistry, biochemical engineering or similar disciplines with a minimum of 2-5 years viral-manufacturing industry experience; Expert knowledge of scientific principles and concepts;
- Foundational knowledge in process development with a working experience of chromatographic and advanced filtration methods is highly preferred;
- Working knowledge of Quality Assurance and Quality Control in a biosafety-contained biologics production setting is required;
- Experience in preparation of SOP and BPR documents highly desirable;
- Excellent software and computer skills including Unicorn, Microsoft Office applications; electronic batch records and LIMS systems a plus;
- Demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments, leading to innovative solutions;
- 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);
Benefits offered include: Health, dental, vision, life, paid vacation and sick leave.
To obtain additional information please contact email@example.com
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, marital status, disability status, protected veteran status, or any other protected class.