Job description
NovaBio Therapeutics is a forward‑looking biotechnology company devoted to delivering transformative therapies through innovative bioprocess development. Located in the Cambridge biomedical ecosystem, we combine cutting‑edge biology with scalable manufacturing to bring safe and effective products to patients.
We are seeking a Senior Scientist to join our Bioprocess Development team. This role provides hands‑on leadership in process optimization, scale‑up activities, and cross‑functional collaboration with Analytical, Formulation, and Quality groups. If you are passionate about translating laboratory breakthroughs into robust, scalable manufacturing processes, we want to hear from you.
Responsibility
- Lead design and execution of bioprocess development experiments to optimize yield, purity, and process robustness across lab and pilot scales.
- Develop and implement scale‑up strategies from bench to pilot scale, ensuring consistency and product quality.
- Collaborate with Analytical and QC teams to define critical quality attributes, in‑process controls, and release criteria.
- Apply DOE, statistical analysis, and data visualization to drive data‑driven decision making.
- Troubleshoot process deviations, perform root cause analysis, and drive continuous improvement initiatives.
- Mentor and supervise junior scientists; contribute to training, SOPs, and knowledge transfer.
- Prepare technical reports, study protocols, and regulatory documentation as needed for development programs.
Qualification
- PhD in Biotechnology, Bioengineering, Chemical Engineering, or related field; or Master's with 5+ years of relevant industry experience.
- 5+ years in bioprocess development or GMP manufacturing environments, ideally with mammalian or microbial systems.
- Solid experience with bioreactor operations, scale‑up, and process characterization.
- Proficient in DOE, statistics, and data analysis tools (Python, R, JMP, or equivalent).
- Strong knowledge of GMP/Regulatory expectations and experience with keeping comprehensive technical documentation.
- Excellent communication and collaboration skills; proven ability to lead cross‑functional projects and mentor team members.
- Adaptable, detail‑oriented, and capable of managing multiple priorities in a fast‑paced setting.