Your primary focus will be on designing, executing, and optimizing upstream Lentiviral Vector (LVV) processes with a primary focus on suspension bioreactor platforms at clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs.

Key Responsibilities:

• Plan and perform experiments to develop and optimize LVV upstream processes for suspension cell culture (transient or stable producer cell systems), targeting improvements in titer, quality, robustness, and cost.

• Execute unit operations across seed, production, and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and use scale-down models for characterization and comparability.

• Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fit for-purpose knowledge records.

• Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, root cause analysis, and corrective actions.

• Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with cGMP principles for late-stage readiness.

• Work closely with Analytical Development on assay readiness and in process testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.

• Apply Lean practices and digital tools for scheduling, data integrity, and reproducibility; track KPIs (titer, infectivity, impurity profiles, cycle time, right first time) and recommend improvements.

Qualifications:

• Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands-on industry experience.

• Experience: Hand-on experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.

• Technical Skills: Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, single-use rocking-platform and stirred-tank bioreactors, and upstream-harvest interfaces; working knowledge of statistical DOE and data analytics tools.

• GMP Readiness: Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus.

• Communication & Teamwork: Strong written and verbal communication skills; ability to work effectively in cross-functional, matrixed teams; demonstrated problemsolving and troubleshooting capability.

• Tools & Automation: Experience with single-use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.

Preferred Qualifications:

• Demonstrated success scaling suspension LVV processes to pilot/clinical scales and sustaining performance via monitoring and continuous improvement.

• Experience linking upstream parameters to analytical outcomes (titer, infectivity/potency, residuals/impurities) to guide process decisions.

• Contributions to regulatory filings (data tables, process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.

• Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.

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