Job description
BioNova Therapeutics is a leader in regenerative medicine and biologics development. We are expanding our state-of-the-art manufacturing and process development capabilities and seek a Senior Bioprocess Engineer to drive scalable bioprocesses from lab to clinic.
In this role, you will partner with R&D, QA, and Manufacturing to design, optimize, and troubleshoot upstream bioprocesses, including mammalian and microbial platforms. You will own process scalability, tech transfer to GMP facilities, and contribute to CMC documentation for regulatory submissions.
Responsibility
- Lead development of scalable upstream bioprocesses from bench to pilot scale, including pilot plant assessment and scale-up strategies.
- Design and execute DOE experiments to optimize yield, titer, product quality, and process robustness.
- Collaborate with R&D, Manufacturing, QA, and Regulatory to ensure smooth tech transfer to GMP facilities and scale-up plans.
- Develop and maintain process documentation, SOPs, batch records, and tech transfer packages for regulatory submissions.
- Implement quality by design principles, apply PAT tools, and monitor process analytics to control variability.
- Investigate deviations, implement CAPAs, and drive continuous process improvement using statistical analysis.
- Support regulatory interactions, participate in risk assessments, validation activities, and equipment qualification as needed.
Qualification
- MS or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
- 5+ years in bioprocess development or upstream manufacturing in biotech or pharmaceutical settings.
- Experience with upstream processes for mammalian or microbial systems, including CHO, HEK, or microbial hosts.
- Proficiency with analytical methods (HPLC, ELISA, qPCR), along with DOE, statistics, and data analysis tools (Python, JMP, Minitab).
- Strong knowledge of cGMP, regulatory expectations, and hands-on tech transfer experience to GMP facilities.
- Excellent communication and cross-functional collaboration skills; proven ability to lead projects and document technical information clearly.
- Hands-on experience with bioreactors from benchtop to pilot scale; strong aseptic technique and facility operations knowledge.