Summit Therapeutics

Senior Manager/Associate Director, Downstream MSAT

Princeton, NJ · Director

Sponsorship not specified$148k-$185kDetected 8 days ago

Data AnalysisSupply ChainRecruitingCustomer SupportClinical TrialsCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

The ideal candidate will have proven technical ability, commercial control strategy authorship, and module 3 BLA/MAA authorship experience specifically supporting biologics drug substance.

Contribute to and have accountability for all Summit Downstream CMC activities, focusing on control strategy development, process validation, continued process verification, and technical troubleshooting to support drug substance and product (as needed)
Support phase-appropriate downstream process development, characterization, validation, and technology transfers to or between external CDMOs for drug substance (DS).
Contribute significant strategic direction and authorship of regulatory documents including clinical IND/IMPD and commercial BLA/MAA
Assess and manage process risks arising from manufacturing or process changes.
Develop effective working relationships with Summit project team members and external Contract Manufacturing Organizations (CMOs).
Support MSAT team objectives while providing clear and concise updates of results and reports to the project team leaders, including the Head of CMC.
Support CMC sub-teams and programs.
Provide technical support to manufacturing operations, addressing and resolving any issues that arise during downstream processing.
Drive continuous improvement to enhance process robustness, efficiency, and scalability.
Manage process deviation investigations and change controls.

Degree in chemical engineering, biotechnology, pharmaceutical science, or a related field.
Bachelor's degree with 12+ years of relevant experience
Master's degree with 10+ years of relevant experience
PhD with 8+ years of relevant experience.
Experience with technology transfer across different systems, scales, and sites is highly valued
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.

Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus
Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs.
Excellent attention to detail and organizational skills, with a focus on quality and technical excellence.
Good information management and data organization skills
A track record of working under pressure and delivering high-quality results to tight deadlines.

$148,000 - $185,000 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.

Experience with health authority inspection and information request responses highly desired
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.