We are seeking a collaborative, detail‑oriented, and safety‑focused biochemical/bioprocess engineer to design, develop, and optimize bioprocesses, biochemical assays, and upstream/downstream workflows that support research, pilot operations, and product development. The successful candidate will work closely with multidisciplinary teams across R&D, process engineering, analytics, quality, and manufacturing to deliver robust, scalable bioprocess solutions, troubleshoot fermentation and purification challenges, and ensure reproducible, compliant laboratory and pilot plant operations. This role requires strong hands‑on bioprocess and analytical skills, careful experimental design, clear cross‑team communication, and a commitment to safety, sustainability, and continuous improvement.

Key Responsibilities

• Design, develop, and optimize microbial and cell‑based upstream processes (strain selection, media development, seed trains, bioreactor operation, scale‑up strategies) to meet yield, productivity, and quality targets.

• Develop and optimize downstream purification workflows (centrifugation, filtration, chromatography, tangential flow filtration, viral clearance where applicable) to achieve product purity, recovery, and scalability goals.

• Plan and execute process characterization experiments, including small‑scale and pilot bioreactor runs, process parameter mapping, and scale‑down models to support process understanding and control strategies.

• Implement and validate analytical assays for in‑process monitoring and product characterization (HPLC, SEC, ELISA, qPCR, SDS‑PAGE, mass spectrometry, spectrophotometry), and interpret data to guide process decisions.

• Perform data analysis and statistical interpretation (DOE, PAT, multivariate analysis), iterate on process parameters, and maintain clear electronic lab and batch records to support reproducibility and regulatory submissions.

• Collaborate with cross‑functional teams (formulation, quality, manufacturing, regulatory) to support process transfer, tech‑transfer activities, and scale‑up to pilot and production environments.

• Assess process robustness, process safety, and environmental impact; recommend process improvements to increase efficiency, reduce waste, and support sustainability goals.

• Support vendor selection, equipment qualification, and incoming raw material characterization; coordinate procurement of biological reagents and manage material certificates and cold‑chain logistics where applicable.

• Participate in root cause analysis, failure investigations, and corrective and preventive actions (CAPA) for process or product quality issues; document lessons learned and update SOPs and work instructions.

• Contribute to the development and maintenance of standard operating procedures (SOPs), training materials, and safety protocols; mentor junior staff and foster an inclusive, team‑oriented lab and pilot plant culture.

Required Qualifications - Skills & Experience

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or a closely related discipline, or equivalent hands‑on laboratory and pilot plant experience.

• 3+ years of practical experience in bioprocess development, fermentation, and downstream processing in a research, development, or industrial setting.

• Hands‑on experience with upstream bioreactor operation (bench and pilot scale), aseptic technique, and cell culture/microbial cultivation; familiarity with scale‑up principles and mass/energy balances.

• Practical experience with common downstream unit operations (filtration, chromatography, concentration) and analytical methods for product quality assessment.

• Experience with process characterization tools (DOE, process capability studies), PAT technologies, and statistical analysis of process and QC data.

• Proficiency with laboratory documentation practices, electronic lab notebooks (ELNs), and data analysis tools (Excel; Python/R/Matlab experience advantageous).

• Excellent verbal and written communication skills: able to prepare clear technical reports, present results to cross‑functional teams, and collaborate with internal and external stakeholders.

• Commitment to biosafety, regulatory compliance, and ethical practices in biological materials handling and testing; familiarity with biosafety levels, sterile practices, and safety data sheets.

• Strong problem‑solving skills, attention to detail, and ability to manage multiple project priorities in a fast‑paced environment.

Preferred Qualifications - Domain & Tools

• Advanced degree (MS/PhD) in Biochemical Engineering, Biotechnology, or related field preferred for roles with greater technical ownership of process development.

• Experience with aseptic pilot plant operations, single‑use technologies, and cleanroom practices beneficial for scale‑up and manufacturing transfer.

• Familiarity with regulatory frameworks (GLP, GMP) and experience supporting regulatory submissions or validations advantageous for regulated product development.

• Experience with LIMS, process control systems (SCADA/DCS), and version control for process recipes and batch records.

• Training or certifications in biosafety, hazardous materials handling, process safety management, or quality systems (ISO) are advantageous.

Work Environment & Compensation

• Full‑time position within an interdisciplinary R&D and pilot operations organization; primarily laboratory and pilot‑plant based with periodic cross‑site collaboration and meetings.

• 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, conference participation, and career growth within a diverse, inclusive, and safety‑focused workplace.

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