Summit Therapeutics, Inc. · 1 hour ago
Associate Director, CMC/Quality Project Management (Biologics)
Princeton, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$153K/yr - $180K/yr
8+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Associate Director, CMC/Quality Project Management will lead CMC and Quality deliverables across the biologics development lifecycle, collaborating cross-functionally to ensure high-quality submissions and commercialization readiness.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Cross-functional Collaboration and CMC Leadership
Represent the Program Management department in cross-functional teams with clinical development, non-clinical and/or regulatory focus
Integrate Analytical Development/Quality Control (QC), Drug Product development and manufacturing, and end-to-end Supply Chain to ensure robust control strategies, inspection readiness, and reliable supply
Develop and maintain detailed CMC submission plans, timelines, and risk mitigation strategies for BLA and other regulatory filings
Prepare high-impact presentations, decision memos, and status reports for senior management and governance forums
Can quickly build strong and sustaining relationships with stakeholders at all levels
Lead key activities or assigned projects, which may rapidly evolve based on business needs
Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations
Ensure alignment in CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization, control strategy, comparability, stability, regulatory expectations)
Ensure alignment of CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making
Engage in cross-functional governance and steering committees to influence and guide program direction
Monitor global regulatory trends (FDA, EMA, PMDA, ICH) to anticipate changes and manage compliance strategies in submissions
Maintain decision-quality approaches within assigned areas with options and trade-off assessments
Actively identify, track and mitigate risks, to include opportunity creation that may accelerate project success
Develop, implement and maintain CMC plans for assigned activities, to include scenario planning, dashboards, reports and timelines that integrate into overall Program Plans. Communicate CMC plans to cross-functional team and leadership
Lead assigned internal and external communications outputs
Serve as the primary CMC PM interface for CDMOs/CMOs performing drug substance, drug product, and analytical testing
Monitor CDMO performance against KPIs (batch production and release, deviation closure, CAPA effectiveness) and escalate risks proactively
Drive method transfer, tech transfer, and validation activities at CDMOs to meet regulatory and program timelines
Support audit readiness and participate in vendor audits as needed
Limited travel may be required depending on assigned activities or projects, plus flexibility for global virtual meetings in different time zones. Ability to travel globally may be needed, including EU and meeting Chinese Visa requirements
All other duties as assigned
Qualification
Required
Bachelor's degree in life sciences, chemistry, engineering, or related field required
Minimum of 8+ years in pharmaceutical/biotech industry, with substantial experience in CMC development, late-stage biologics, and regulatory filing preparation (BLA, MAA)
Proven success leading global, matrixed, cross-functional teams in a regulated environment
Strong skills in integrated project planning (PMP certified), risk management, resource allocation, and budget oversight
Prior pharmaceutical (drug development) experience required, late-stage to commercialization phase experience and biologics preferred
Proficient user of MS Office suite (e.g., PowerPoint, Word, Excel, Project), experience using electronic document management systems, document review tools and can quickly build presentations for leaders/teams
Excellent communicator in public-speaking, meeting facilitation and email communication
Ability to excel in a fast-paced, demanding and diverse environment
Preferred
Advanced degree (MS, PharmD, PhD, MBA) desirable
Professional proficiency in Mandarin is strongly preferred to facilitate communication with overseas collaborators
Experience with tools like Smartsheet, MS Project, Power BI, Office Timeline etc., is beneficial
Prior oncology experience in late-stage development and understanding of GMP, manufacturing and global regulatory supply chains preferred
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