Manager Downstream Process Development

EPM Scientific; Wisconsin; On-site; USD 100,000 - 150,000; Full time

Job summary

EPM Scientific in Wisconsin seeks an experienced Manager, Downstream Process Development to lead a team of 5–6 scientists across biologics, cell and gene therapy programs. You will direct downstream development, scale-up, and technology transfer to cGMP manufacturing, partnering with Manufacturing, MS&T, Quality, and Analytical Development.

You will apply QbD to define critical process parameters and control strategies, mentor staff, and drive timely delivery while ensuring compliance and strong

Qualifications

• Minimum of 10+ years of biopharmaceutical industry experience with leadership
• Experience in downstream process development and scale-up for biologics and gene therapies
• Strong experience with chromatography, filtration, viral clearance, and formulation
• Proven ability to manage 3–5 direct reports and coach performance
• Regulated manufacturing environments (cGMP/CDMO/CMO) experience

Responsibilities

• Lead, mentor, and develop a team of 5–6 direct reports, overseeing workload and experimental execution.
• Provide technical leadership for downstream process development, scale-up, and characterization.
• Support purification processes involving chromatography, UF/DF, filtration, viral clearance, and formulation.
• Apply QbD to define CPPs, CQAs, and control strategies.
• Lead technology transfer into cGMP manufacturing and support PPQ readiness.
• Serve as SME in client meetings and address escalations.
• Drive on-time delivery and adherence to project scope and safety policies.

Skills

Downstream process development

Team leadership

Chromatography

Filtration

Viral clearance

QbD principles

cGMP manufacturing

Client-facing communication

Project management

Education

Bachelor’s degree

Master’s degree

PhD

Job description

Manager Downstream Process Development (PR/607820) Wisconsin, USA

Salary: USD100000 - USD150000 per year

Manager, Downstream Process Development

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.