Summit Therapeutics, Inc. · 5 hours ago
Director, Drug Product, Technical Operations (Princeton, NJ or Oxford, UK )
Princeton, NJ
Full-time
Onsite
Director/Executive
$184K/yr - $230K/yr
12+ years expSummit Therapeutics, Inc. is focused on developing innovative therapies, including their investigational bispecific antibody Ivonescimab. They are seeking a highly experienced Director of Drug Product Technical Operations to lead late-phase clinical and commercial manufacturing activities, ensuring readiness for BLA filing and overseeing compliance with regulatory expectations.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Partner with MSAT to implement product, process, and site changes, ensuring robust technical oversight and documentation
Lead end-to-end manufacturing operations for sterile drug product, including oversight of CMOs and internal teams
Ensure successful execution of clinical batch manufacturing in alignment with development timelines and quality standards
Drive readiness for BLA filing and commercial launch, including validation and PPQ strategy
Ensure successful execution of commercial batch manufacturing in alignment with supply plan and quality standards
Lead investigations and root cause analyses for manufacturing deviations and implement corrective actions
Develop and execute manufacturing strategies aligned with program milestones and regulatory requirements
Collaborate cross-functionally with Regulatory, Quality, Supply Chain, and CMC teams to ensure integrated planning and execution
Manage budgets, timelines, and resources for manufacturing operations
Ensure GMP compliance across all manufacturing activities
Support audits and inspections
Maintain strong documentation practices and contribute to regulatory submissions
All other duties as assigned
Qualification
Required
Bachelors degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field; PhD or MS preferred
Minimum of 12+ years of experience in biologics manufacturing, with a focus on sterile drug product and late-phase development
Proven track record in BLA preparation, PPQ, and commercial launch
Strong knowledge of regulatory expectations (FDA, EMA) for biologics
Experience managing external manufacturing partners and internal cross-functional teams
Excellent leadership, communication, and project management skills
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 (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 Board Member
Recent News
The Motley Fool
2026-01-13
Company data provided by crunchbase