Process Engineer (Upstream)
Job Title: Process Engineer (Upstream)
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 provide technical expertise in upstream process development for the GMP production of F1’s family of lentivirus vectors.
Responsibilities to include:
- Continue scaling of first generation suspension-based fermentation process for virus production from seed banks through clarified harvest.
- Optimize scaling to support disposable tank fermentation processes;
- Develop media optimization, fermentation processes and feed strategies for second generation cell substrates;
- Develop electronic BPRs for transfer to GMP in multiple sites
- Collaborate with downstream PD and analytical groups to develop commercial scale processes
- Develop processes with QbD principles
- Develop and draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities.
- Maintain and calibrate the critical equipment for intended use, provide trouble-shooting and training when necessary.
- Source critical raw materials and reagents required to meet the specifications set. Provide logistics support for production components.
- Support the organization in maintaining a work environment focused on quality and that fosters open communication, collaboration, integration, and teamwork.
- Other duties as required commensurate with the candidate’s background and skillset.
- Aid in the authoring of CMC documents;
Qualifications and Skills
- MS degree with 4-7 years or BS degree with over 5 years of experience in upstream process and cell line development area. Experience with cGMP Manufacturing under cGMP compliance is a plus.
- Demonstrated ability to troubleshoot, quickly design and execute thoughtful experiments, leading to innovative solutions; DoE a plus;
- Excellent software and computer skills, especially Microsoft Office applications; electronic batch records and LIMS systems a plus;
- 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.