Summit Therapeutics, Inc. · 11 hours ago
Sr Manager, MSAT, DSP
Princeton, NJ
Full-time
Onsite
Senior Level
$155K/yr - $180K/yr
6+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Sr Manager, MSAT, DSP will oversee downstream-related activities, ensuring operational and technical oversight to support drug substance production and collaborate with external partners and internal teams.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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)
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)
Assist in the authorship, update, and/or review of regulatory filings
Support MSAT team objectives while providing clear and concise updates of results and reports to the project team leaders, including the Head of CMC
Work in close partnership with process scientists & engineers, QA, RA, supply chain, consultants, and cross-functionally
Support CMC sub-teams and programs
Facilitate problem-solving, contingency planning, and decision-making
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
Oversee tech transfer activities to ensure a seamless transition from development to manufacturing
Manage process deviation investigations and change controls
Travel as needed to support technology transfer, process scale-up, and collaboration with external partners
Perform all other duties as assigned
Qualification
Required
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
Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing in a biological environment (preferably mAbs) is essential
Proven technical knowledge in various systems (e.g. Unicorn, Delta V, etc) and demonstrated proficiency in all downstream-related operations, including but not limited to Affinity (Protein A), Ion Exchange, Mixed-Mode, and Hydrophobic Interaction Chromatography, Virus Filtration, and Ultrafiltration / Diafiltration
Proven track record with process scale-up and technology transfer, moving from bench scale to pilot and production plant
Experience with technology transfer across different systems, scales, and sites is highly valued
Experience in late-stage process development, characterization and validation is highly valued
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
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
A track record of working under pressure and delivering high-quality results to tight deadlines
Preferred
IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred
Data Analytics experience including JMP and other data organization (AI-based or not) platforms a strong plus
Benefits
Bonus
Stock
Benefits and/or 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 (3)
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 Chief Financial Officer
Recent News
Company data provided by crunchbase