Manager Downstream Process Development
Manager, Downstream Process Development
Location: Wisconsin | Onsite
Relocation: Support available
Overview
Our firm is currently supporting a leading biopharmaceutical development and manufacturing organization in the search for a Manager, Downstream Process Development.
This individual will lead a team of 5 to 6 scientists supporting downstream process development, scale-up, characterization, and technology transfer across biologics and cell and gene therapy programs. The role will also serve as a key technical partner to external clients and collaborate closely with Manufacturing, MS&T, Quality, and Analytical Development.
Responsibilities
- Lead, mentor, and develop a team of 5 to 6 direct reports, overseeing workload, study design, and experimental execution.
- Provide technical leadership for downstream process development, optimization, scale-up, and characterization.
- Support purification processes involving chromatography, UF/DF, normal-flow filtration, viral clearance, and formulation.
- Apply QbD principles to define critical process parameters, critical quality attributes, and appropriate control strategies.
- Lead technology transfer into cGMP manufacturing and support scale-down models, risk assessments, PPQ readiness, and manufacturing troubleshooting.
- Serve as a technical subject-matter expert in client meetings, providing recommendations and addressing technical escalations.
- Drive on-time delivery, right-first-time execution, training compliance, safety performance, and adherence to project scope.
Qualifications
- Bachelor's degree with 10+ years, Master's degree with 8+ years, or PhD with 4+ years of relevant biopharmaceutical industry experience in chemical engineering, biochemistry, biotechnology, or a related scientific discipline.
- Minimum of four years of formal people leadership experience required.
- Must have directly managed at least 3 to 5 employees, including responsibility for coaching, performance management, and workload allocation.
- Strong experience in downstream process development and scale-up supporting biologics and/or cell and gene therapy products.
- Technical expertise across chromatography, filtration, viral clearance, formulation, and process characterization.
- Practical experience working within a cGMP manufacturing, CDMO, CMO, or similarly regulated environment.
- Experience transferring processes into manufacturing and supporting technical troubleshooting.
- Strong client-facing communication skills with the ability to translate complex technical findings into clear recommendations.
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