Job description
NovaBio Therapeutics is a fast-growing biotechnology company pioneering cell-based therapies. We are seeking a Senior Bioprocess Engineer to lead scalable bioprocess development and technology transfer for our cutting-edge programs in cell-based therapies.
In this role, you will partner with R&D, manufacturing, QA/QC, and supply chain to design, optimize, and scale robust bioprocesses from lab to GMP production. You will own process characterization, scale-up studies, and continuous improvement initiatives to ensure robust, reproducible, and cost-effective manufacturing.
Responsibility
- Lead the design, optimization, and troubleshooting of upstream and downstream bioprocesses for mammalian and microbial systems within GMP environments.
- Plan and execute process development campaigns, including DOE, design of experiments, and risk assessment to enable successful tech transfer to manufacturing.
- Develop scalable production processes, define critical process parameters (CPPs), and establish robust control strategies.
- Collaborate with R&D, process development, and manufacturing to propel technology transfer activities and ensure transfer success.
- Implement process analytical technology (PAT) and real-time analytics to monitor product quality and process performance.
- Create comprehensive documentation, batch records, and reports to support regulatory filings and internal audits.
- Mentor junior engineers and lead cross-functional teams on process optimization and troubleshooting.
Qualification
- BS or MS in Chemical/Biochemical Engineering, Biotechnology, or a closely related field; MS preferred.
- 5+ years of hands-on bioprocess development or manufacturing experience, preferably with GMP and technology transfer experience.
- Strong knowledge of upstream/downstream operations, chromatography, filtration, and unit operations.
- Experience with cell-based therapies or mammalian cell culture is highly desirable.
- Proficiency with data analysis tools (Python, JMP, Minitab) and process modeling; excellent problem-solving and communication skills.
- Ability to work cross-functionally in a fast-paced, matrixed organization and to manage multiple priorities.
- Strong documentation and regulatory-compliance mindset with attention to DOEs, risk assessments, and batch records.