Job description
GenNext Biotech is seeking a results driven Senior Bioprocess Engineer to lead scalable production development for therapeutic biologics. Based in Boston, this role offers on site laboratories and manufacturing suites with hybrid work options. You will drive process optimization across GMP facilities from discovery through technology transfer and commercialization.
As a key member of the Process Development team, you will design experiments, analyze data, and implement robust processes that deliver consistent product quality and yield. You will collaborate with cross functional teams including Manufacturing, Quality, Regulatory, and Analytical Development to ensure seamless scale up and transfer to manufacturing.
Responsibility
- Lead design and optimization of upstream and downstream processes for therapeutic biologics to maximize yield and product quality.
- Plan and execute experiments using DoE and statistical analysis to identify process parameters that impact critical quality attributes.
- Scale processes from lab through pilot and manufacturing, ensuring transfer readiness and documentation in the QMS.
- Develop and implement robust control strategies, SOPs, and batch records compliant with GMP and regulatory requirements.
- Collaborate with Manufacturing, QA, Regulatory, and Analytical Development to ensure successful tech transfer and continuous improvement.
- Troubleshoot process deviations, investigate root causes, and implement sustainable corrective actions.
- Mentor junior engineers, present findings to management, and contribute to project timelines and risk assessments.
Qualification
- BS or MS in Chemical Engineering, Biochemical Engineering, or a related field.
- 5+ years of hands on experience in bioprocess development and manufacturing of biologics, with knowledge of fermentation or cell culture.
- Proficiency with GMP regulatory expectations and quality systems; experience with quality by design is a plus.
- Strong data analysis skills; proficient in DoE, statistics, and data visualization; experience with JMP or Python is a plus.
- Experience with upstream and downstream operations including bioreactors, centrifugation, filtration, and chromatography.
- Excellent problem solving, communication, and cross functional collaboration abilities.
- Ability to work in a fast paced environment and manage multiple projects with competing priorities.