Summit Therapeutics, Inc.

Senior Manager, Upstream MSAT

Summit Therapeutics, Inc.

full-time

Posted on:

Location Type: Office

Location: Princeton • New Jersey • 🇺🇸 United States

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Salary

💰 $168,000 - $190,000 per year

Job Level

Senior

About the role

  • Lead and support upstream process design, optimization, troubleshooting, and tech transfer for drug substance manufacturing.
  • Drive process development, characterization, validation, and risk management across internal teams and external CDMOs.
  • Collaborate cross-functionally with QA, RA, supply chain, and CMOs; provide clear updates to project leadership.
  • Contribute to regulatory documentation and support CMC programs and sub-teams.
  • Support BLA filing and related activities, including responding to RFIs, preparing for PAI, PAS submissions, annual product reviews, and other regulatory commitments.
  • Resolve upstream manufacturing issues and facilitate problem-solving and contingency planning.
  • Promote continuous improvement for process robustness, efficiency, and scalability.
  • Oversee tech transfer and manage deviations, change controls, and risk assessments.
  • Travel as needed for tech transfer, scale-up, and external collaboration.
  • Perform all other duties as assigned.

Requirements

  • Bachelors degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field; MS or PhD preferred.
  • Minimum of 6+ years of experience in biologics DS manufacturing with emphasis on late-phase monoclonal antibody development.
  • Proven ability to design and execute Design of Experiments (DoE) studies, including multivariate data analysis and interpretation to optimize process parameters and enable data-driven decisions.
  • Demonstrated success in process scale-up and technology transfer from bench to pilot and commercial scale.
  • Strong background in tech transfer across multiple systems, scales, and manufacturing sites.
  • Hands-on experience in scale-down model qualification (SDMQ), process characterization (PC), validation (PV), and PPQ campaigns is strongly preferred.
  • Experience in authoring regulatory submissions, including IND, IMPD, and BLA documentation, is strongly preferred.
  • Familiarity with cell line development and media optimization is a plus.
  • Exceptional attention to detail, organizational skills, and commitment to quality and technical excellence.
  • Strong interpersonal skills; able to work independently, in cross-functional teams, and with external partners and regulators.
  • Proven ability to deliver high-quality results under pressure and tight timelines.
Benefits
  • Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
upstream process designprocess optimizationtroubleshootingtech transferprocess developmentvalidationrisk managementDesign of Experiments (DoE)process characterizationscale-up
Soft skills
attention to detailorganizational skillscommitment to qualityinterpersonal skillsindependent workcross-functional collaborationability to deliver under pressureproblem-solvingcontingency planningcommunication
Certifications
Bachelors degree in EngineeringBachelors degree in BiochemistryBachelors degree in Pharmaceutical SciencesMS or PhD preferred