Summit Therapeutics, Inc. · 7 hours ago
Executive Director, Analytical Sciences
Princeton, NJ
Full-time
Onsite
Director/Executive
$260K/yr - $280K/yr
15+ years expSummit Therapeutics, Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Executive Director, Analytical Sciences will provide strategic and operational leadership for analytical activities supporting the development and commercialization of the company's lead bispecific antibody product, ensuring regulatory compliance and product control.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Own and continuously evolve the global analytical control strategy for clinical and commercial drug substance and drug product
Ensure analytical readiness to support BLA review, responses to regulatory questions, inspections, and post-approval commitments
Define analytical lifecycle management strategies aligned with ICH Q2/Q6/Q12 and global regulatory expectations
Provide oversight and scientific leadership for:
Method development and optimization
Method qualification and validation
Method transfer to internal and external laboratories
Ensure analytical methods are phase-appropriate, robust, stability-indicating, and fit for commercial use
Troubleshoot complex analytical issues related to bispecific antibodies (e.g., heterogeneity, potency, binding, impurities)
Accountable for all drug substance and drug product release and stability testing conducted at external CDMOs and partner labs
Ensure compliance with cGMP, data integrity, and regulatory filing requirements
Review and approve analytical protocols, reports, deviations, OOS/OOT investigations, and change controls
Lead analytical governance across a virtual network of CDMOs, contract labs, and development partners
Set expectations, KPIs, and quality standards for external analytical execution
Serve as the primary analytical escalation point for CDMO performance, compliance, and technical issues
Act as the analytical subject-matter expert for global regulatory interactions
Author, review, and approve analytical sections of:
BLAs, MAAs, and IND/IMPD amendments
Regulatory responses and briefing packages
Support regulatory inspections, audits, and health authority meetings
Partner closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain
Contribute to overall CMC strategy, risk management, and commercialization planning
Build scalable analytical capabilities aligned with future pipeline expansion
Qualification
Required
PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field (MS with extensive relevant experience considered)
15+ years of progressive experience in analytical sciences within the biopharmaceutical industry
Demonstrated leadership in late-stage development and commercial biologics
Direct experience supporting BLA/MAA submissions and approvals
Strong expertise in monoclonal and/or bispecific antibodies
Proven success operating within virtual or highly outsourced CMC models
Deep knowledge of physicochemical and functional characterization of biologics
Potency, binding, and cell-based assays
Stability programs and comparability strategies
Strong understanding of GMP, ICH, FDA, EMA, and global regulatory requirements
Experience managing analytical aspects of process changes, scale-up, and post-approval lifecycle management
Strategic thinker with a commercial mindset
Comfortable operating in ambiguity and fast-paced, resource-lean environments
Strong external partner and stakeholder management skills
Excellent written and verbal communication, including regulatory writing
Hands-on leader capable of balancing strategic oversight with technical depth
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 Chief Financial Officer
Recent News
Company data provided by crunchbase