Job description
NovaBio Therapeutics is seeking a Senior Bioprocess Engineer to advance scalable biologics development in our Cambridge, MA facility. You will lead end-to-end bioprocess development for mammalian systems, drive process optimization, and collaborate across R&D, QA/QC, and manufacturing to deliver high-quality therapies to patients.
We offer a competitive compensation package, equity, and a collaborative, fast-paced environment that values curiosity, integrity, and patient impact.
Responsibility
- Lead design, optimization, and scale-up of mammalian bioprocesses (fed-batch and perfusion) from lab to pilot/clinical scales.
- Develop and implement robust analytical assays and process control strategies for in-process and release testing.
- Plan and execute DOE studies to characterize process windows and identify causes of variation.
- Collaborate with R&D, QA/QC, and manufacturing to ensure GMP compliance and successful tech transfer to production.
- Mentor junior scientists, manage project timelines, and contribute to cross-functional product development plans.
- Drive continuous improvement initiatives to enhance productivity, yield, and product quality while maintaining safety and compliance.
- Author and review technical documents, SOPs, deviations, CAPAs, and change controls.
Qualification
- PhD in Biotechnology, Chemical Engineering, or a related field; or MS with 5+ years of industry experience in bioprocess development.
- Hands-on expertise with mammalian cell culture, bioreactors, harvest, and downstream purification processes.
- Strong knowledge of GMP, regulatory expectations, and quality systems for biologics.
- Experience with DOE, process characterization, data analysis (JMP, Minitab, Python), and statistical thinking.
- Excellent communication, collaboration, and leadership skills; proven ability to mentor teams and manage projects.
- Familiarity with analytical methods, in-process controls, and quality by design (QbD) concepts.
- Willingness to travel for collaborations, audits, and tech transfer as needed.