Summit Therapeutics

Senior Manager, Upstream MSAT

Princeton, NJ · Senior

Sponsorship not specified$148k-$175kDetected 12 days ago

Data AnalysisProject ManagementProcess ImprovementRecruitingCustomer SupportClinical TrialsGMPCell CultureLeadershipCommunicationCollaboration

About the role

The ideal candidate brings strong expertise in mAb upstream processing, process characterization, control strategy development, and lifecycle management.

Provide technical support and leadership for upstream process characterization, validation, and commercial manufacturing support, including process optimization and troubleshooting.
Lead technology transfer activities across internal teams and CDMOs, including scale-up, PPQ execution, and commercial readiness, serving as the primary technical interface with external partners.
Support clinical and commercial manufacturing by ensuring alignment with development timelines, supply plans, and operational readiness.
Assess and manage process risks and lifecycle changes, including risk assessments, deviation investigations, root cause analysis, CAPA, and change control.
Oversee PPQ execution and commercial manufacturing support, including person-in-plant activities, ensuring GMP compliance, data integrity, and inspection readiness (PLI/PAI).
Lead change control activities, including impact assessments, and collaborate with Quality and Technical Operations on the development and execution of implementation plans.
Drive continuous improvement initiatives to enhance process robustness, scalability, and operational efficiency.
Travel as needed to support manufacturing, technology transfer, and CDMO oversight.
Perform other duties as assigned.

Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field.
Bachelor's degree with 8+ years of relevant experience
Master's degree with 6+ years of relevant experience
PhD with 3+ years of relevant experience.
All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Direct experience in process scale-up and technology transfer across scales, systems, and manufacturing sites, including transfer from development through commercial manufacturing
experience with large-scale (>10 kL) stainless steel bioreactors and centrifugation transfer is a plus.
Experience in late-stage process development, characterization and validation is highly valued
Experience authoring IND/IMPD and BLA/MAA Module 3 content, as well as CPV (Continued Process Verification), is highly preferred.

Good information management and data organization skills
A track record of working under pressure and delivering high-quality results to tight deadlines.

$148,000 - $175,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Author and review regulatory submissions (IND/IMPD/BLA/MAA Module 3 sections) and provide technical support for health authority interactions.
Educational Background:

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.