Summit Therapeutics, Inc. · 2 days ago
CMC Manager, Drug Substance
Princeton, NJ
Full-time
Onsite
Mid, Senior Level
$118K/yr - $140K/yr
5+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The CMC Manager, Drug Substance will manage and oversee CMC activities related to drug substance development and production, ensuring compliance with regulatory requirements and supporting the overall drug development process.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Support the Director, CMC, Drug Substance in managing and overseeing all CMC activities related to drug substance development and production
Assist in managing outsourcing of manufacturing activities, including working with Contract Development and Manufacturing Organizations (CDMOs)
Collaborate with internal teams and external partners to ensure timely and efficient execution of CMC projects
Assist in developing and implementing CMC strategies to support drug development and regulatory submissions
Review and approve CMC documentation, such as development protocols, reports, batch records, and regulatory submissions
Ensure compliance with GMP, ICH, EMA, and FDA regulations throughout the CMC process
Work closely with Quality Assurance, Regulatory Affairs Supply Chain, and other departments to ensure alignment and successful project outcomes
Monitor and manage project timelines, budgets, and resources to ensure project goals are met
Identify and mitigate risks associated with CMC activities and develop contingency plans as needed
Provide technical expertise and guidance to the CMC team and other stakeholders
Assist in the data analysis of manufacturing, clinical, and commercial data to support ongoing processes
Support the planning and budgeting activities in collaboration with the Director, CMC, Drug Substance
Ensure quality standards are met throughout the CMC process and support quality assurance activities
Collaborate with the Quality Assurance team to address any quality-related issues and implement corrective actions
Work closely with the supply chain department to ensure seamless coordination and integration of CMC activities with supply chain operations
All other duties as assigned
Qualification
Required
Degree in Biotechnology, Chemistry, Biochemistry, Biochemical/Chemical Engineering, or a related field
A minimum of 5 years of proven experience in the biotechnology or pharmaceutical industry, specifically focusing on CMC activities in biologics
Experience with CMC biologics is essential
Strong understanding of drug substance development, process development, and manufacturing
Demonstrated expertise in regulatory submissions and compliance with GMP, ICH, EMA, and FDA regulations
Understanding of quality assurance and maintaining quality standards throughout the CMC process
Excellent project management skills, with the ability to manage multiple projects simultaneously
Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
Ability to travel as needed for business purposes
Preferred
Experience in late-stage clinical and commercial phases is preferable
Advanced degree preferred
Understanding of drug product manufacturing would be beneficial
Mandarin language is a plus
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
2025-12-09
2025-12-05
Company data provided by crunchbase