MSAT Director - Drug Product jobs in United States
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Summit Therapeutics, Inc. · 1 day ago

MSAT Director - Drug Product

positionUnited States
timeFull-time
remoteRemote
seniorityDirector/Executive
money$190K/yr - $230K/yr
date10+ years exp

Summit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving the quality of life through innovative therapies. They are seeking a highly experienced and strategic Director of MSAT - Drug Product to lead process development, technology transfer, and regulatory interactions in preparation for commercialization of their main asset.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Lead process development/characterization, tech transfer and process validation for sterile drug product, including oversight of external CDMOs and internal teams
Partner with the broader CMC team to implement process, product, and site changes
Support, with the team, successful execution of clinical and commercial batch manufacturing in alignment with the development and supply timelines
Be accountable, with the team, to successfully deliver CMC chapters to regulatory documents
Actively support dialogue/interaction with regulatory agencies
Support PLI/PAI preparation and delivery
Responsible for all stages of Process Validation, including CPV (Continuous Process Verification), in accordance with governing quality system requirements
Prioritize post-approval opportunities and develop business cases for further investment/development
Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO’s/CDMO’s
Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes
Collaborate cross-functionally with Regulatory, Quality, Supply Chain, and CMC teams to ensure integrated planning and execution
Ensure GMP compliance across all activities
Support audits and inspections
All other duties as assigned

Qualification

Biologics manufacturingSterile drug productBLA preparationRegulatory expectationsProcess validationProject managementLeadershipCommunicationCollaboration

Required

MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field
Minimum of 10+ 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 and sterile drug product(s)
A strong team player and promotor of inclusion and collaboration
Able to handle multiple projects simultaneously while maintaining high-quality results
Capable of providing and implementing innovative solutions to unique and pressing situations
Experience managing CDMO partners and internal cross-functional teams
Excellent leadership, communication, and project management skills

Preferred

PhD preferred

Benefits

Bonus
Stock
Benefits
Other applicable variable compensation

Company

Summit Therapeutics, Inc.

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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.
dateFounded in 2003
location
Abingdon, Oxfordshire, GBR
people-size201-500 employees
web-link
https://www.smmttx.com/

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 Company
Total Funding
$1.79B
Key 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

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Manmeet Soni
Chief Operating Officer and Board Member
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