Summit Therapeutics, Inc. · 7 hours ago
Sr. Manager, Upstream MSAT
Princeton, NJ
Full-time
Onsite
Senior Level
$168K/yr - $190K/yr
6+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Manager/Senior Manager, Upstream MSAT will lead upstream process engineering activities for the commercialization of Ivonescimab, ensuring successful tech transfer and collaboration with internal and external teams.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field
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
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
Preferred
MS or PhD
Hands-on experience in scale-down model qualification (SDMQ), process characterization (PC), validation (PV), and PPQ campaigns
Experience in authoring regulatory submissions, including IND, IMPD, and BLA documentation
Familiarity with cell line development and media optimization
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
Company data provided by crunchbase