Biochemical/Bioprocess Engineer

We are seeking a collaborative, technically adept, and user-focused Biochemical/bioprocess Engineer to develop, optimize, and scale bioprocesses that enable safe, efficient, and reproducible production of biological products. The successful candidate will partner with research, analytical, manufacturing, quality, and supply chain teams to translate lab-scale processes into robust, GMP-ready manufacturing workflows. This role requires strong biochemical engineering fundamentals, hands-on experience with upstream/downstream process development, and a pragmatic approach to process characterization, control, and transfer.

Key Responsibilities - Biochemical / Bioprocess Engineering

• Design, develop, and optimize upstream and downstream bioprocesses (microbial, mammalian, or cell-free systems as applicable) to meet product quality, yield, and scalability objectives.

• Plan and execute bench- and pilot-scale experiments to characterize critical process parameters and establish robust operating ranges using DOE and statistical analysis.

• Develop and maintain process flow diagrams, batch records, SOPs, and technical transfer documentation to support GMP manufacturing and technology transfers.

• Implement and refine analytical assays and in-process monitoring strategies to inform process control, release criteria, and troubleshooting activities.

• Collaborate with upstream and downstream teams to select and evaluate unit operations (bioreactors, filtration, chromatography, centrifugation, etc.) and ancillary systems for process integration and scale-up.

• Lead>

• Partner with quality and regulatory teams to ensure processes and documentation meet cGMP expectations and support regulatory submissions as needed.

• Mentor and collaborate with scientists, operators, and external partners to transfer knowledge, share best practices, and drive continuous process improvement and technology adoption.

• Support process economics, capacity planning, and resource optimization to align process designs with business goals and manufacturing constraints.

• Engage with vendors and equipment suppliers to evaluate technologies, define integration approaches, and ensure vendor deliverables meet functional and regulatory requirements.

Required Qualifications - Skills & Experience

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Chemical Biology, or a related discipline; equivalent practical experience will be considered.

• 3+ years of hands-on experience in bioprocess development, scale-up, or manufacturing support for biologics, cell therapies, enzymes, or other biologically-derived products.

• Practical experience with upstream (cell culture, fermentation) and downstream (clarification, filtration, chromatography) unit operations and process control strategies.

• Experience designing and interpreting DOE studies, process characterization, and statistical analysis to define critical process parameters and acceptance criteria.

• Familiarity with bioprocess analytical methods (HPLC, ELISA, qPCR, particle analysis, impurity profiling) and ability to collaborate with analytical groups to develop in-process and release assays.

• Working knowledge of regulatory and quality systems relevant to biologics manufacturing, including cGMP principles, documentation practices, and change control workflows.

• Strong problem-solving and troubleshooting skills across biological, mechanical, and process control domains.

• Excellent written and verbal communication skills; able to produce clear technical documentation and present findings to cross-functional stakeholders.

Preferred Qualifications - Domain & Tools

• Experience with pilot-scale and GMP manufacturing environments, including technology transfers and operator training.

• Familiarity with single-use systems, scale-down models, and bioreactor control systems (SCADA/DCS) and automation for process control.

• Knowledge of downstream purification technologies, process modeling tools, and continuous processing approaches.

• Experience with process analytical technology (PAT), real-time analytics, and advanced in-line monitoring strategies.

• Advanced degree (MS/PhD) in a relevant field, or relevant certifications in bioprocess engineering, quality, or regulatory affairs is a plus.

Work Environment & Compensation

• Full-time role within a collaborative, cross-functional product and manufacturing organization; onsite or hybrid presence is expected depending on project needs and facility requirements.

• Competitive salary and benefits package commensurate with experience, including health coverage, retirement plan options, paid time off, and professional development support.

• Opportunities for training, certifications, and career progression in an inclusive, mission-driven organization committed to scientific excellence.

• We are committed to diversity, equity, and inclusion and foster a respectful work environment that supports work-life balance and employee well-being.