Job description
Join NovaGen Biotechnologies as a Senior Scientist in Bioprocess Development. You will lead scalable fermentation and downstream processes for next-generation therapies, collaborating with cross-functional teams to translate early-stage science into robust, GMP-compliant manufacturing processes. This role offers real impact, mentorship, and a clear path to leadership within a fast-growing biotech environment.
In this role you will apply your expertise to design, execute, and optimize lifecycle process development programs from lab to pilot scale, ensuring quality, safety, and regulatory readiness. You will work closely with Manufacturing, Analytical Development, QA, and Regulatory Affairs to deliver repeatable, scalable processes that meet timelines and budget constraints.
We offer competitive compensation, comprehensive benefits, stock options, and a culture of innovation that values curiosity, collaboration, and scientific excellence.
Responsibility
- Lead the design, execution, and optimization of upstream and downstream bioprocess development for scalable production of therapeutic products.
- Plan and conduct experiments for process characterization, media optimization, unit operation scaling, and robustness studies.
- Collaborate with Analytical Development to define release and stability criteria; generate technical documentation for regulatory submissions.
- Develop SOPs, work instructions, change controls, CAPAs, and transfer plans to manufacturing.
- Evaluate new technologies and equipment; implement DOE and statistical analysis to drive data-driven decisions.
- Mentor junior scientists; manage project timelines, milestones, and cross-functional communication.
- Support tech transfer activities to pilot and GMP manufacturing facilities, including scale-up risk assessment and process validation plans.
Qualification
- PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field; or MS with 5+ years of industry experience in bioprocess development.
- 5+ years of hands-on experience in upstream and downstream process development for biopharmaceuticals, preferably for mammalian or microbial systems.
- Strong knowledge of GMP/GLP, regulatory expectations, and quality systems; experience with regulatory documentation is a plus.
- Proficiency with bioreactor operation, purification methods, analytics (HPLC/LC-MS), and process characterization tools.
- Demonstrated expertise in DOE, design of experiments, statistical analysis, and data visualization using tools such as Python, JMP, or R.
- Excellent written and verbal communication; proven ability to present complex data to cross-functional teams and stakeholders.
- Experience with technology transfer to manufacturing and risk assessment; strong problem-solving and collaborative mindset.
- Publication or patent track record is desirable.