Lead, Downstream Process Development (Biologics)

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

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