Job description
NovaBio Therapeutics is seeking a Senior Bioprocess Engineer to join our expanding biomanufacturing team in Boston. This is a high-impact, hands-on role focused on translating early-stage research into scalable, GMP-compliant production processes that enable life-changing therapies.
In this role you will design, optimize, and transfer bioprocesses from laboratory scale to pilot and manufacturing scale, ensuring robust performance and regulatory compliance. You will collaborate across R&D, analytical sciences, QA/QC, and manufacturing to deliver timely, scalable solutions while fostering a culture of safety and continuous improvement.
Responsibility
- Lead design, optimization, and scale-up of bioprocesses from lab to pilot and manufacturing scale, including fermentation and downstream purification.
- Plan and execute DOE experiments, analyze data, and implement process improvements to increase yield, purity, and consistency.
- Develop and maintain GMP-compliant documentation, tech transfer packages, and deviation investigations.
- Collaborate with cross-functional teams (R&D, QA/QC, analytical sciences, manufacturing) to meet project timelines and quality standards.
- Lead technology transfer activities to contract manufacturing organizations (CMOs) and support scale-up campaigns.
- Mentor junior engineers, oversee experimental execution, and promote a culture of safety and best practices.
- Ensure compliance with safety, regulatory, and quality policies and participate in internal and external audits as needed.
Qualification
- PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field; or MS with 5+ years of relevant bioprocess development experience.
- 5+ years of hands-on experience in bioprocess development, fermentation, and/or downstream purification within biotech or pharmaceutical environments.
- Strong knowledge of GMP, PAT, quality systems, and regulatory expectations with experience supporting tech transfer to manufacturing.
- Proficiency in DOE, DOE-based experimentation, statistical analysis, and process characterization.
- Hands-on experience with analytical techniques (HPLC, GC, SDS-PAGE, ELISA) and process analytics; proficiency with data analysis tools (Python, JMP, Minitab).
- Excellent communication, collaboration, and project-management skills; demonstrated ability to lead cross-functional teams.
- Experience working with CMOs and leading technology transfer and scale-up activities.