Centessa Pharmaceuticals
A new kind of pharmaceutical company delivering asset centricity at scale.
Executive Director, CMC
Location
United States
Posted
2 days ago
Salary
$285K - $370K / year
Seniority
Lead
Postgraduate Degree15 yrs expEnglish
Job Description
• Oversee the implementation of end-to-end CMC strategy across Centessa’s development programs
• Translate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functions
• Develop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationships
• Proactively identify and mitigate technical, production, and supply chain risks
• Act as the CMC team representative member in cross-functional developmental teams
• Oversee outsourced manufacturing activities, including CDMO contract negotiations and performance management
• Ensure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches.
• Manage the development of budgets and timelines for CMC operations and report regularly to leadership
• Drive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programs
• Interface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plans
• Assist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+)
• Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activities
• Oversee technical transfer activities of API and drug product for supply chain resilience
• Supervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distribution
• Oversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirements
• Manage analytical method development and validation for starting materials, in-process controls, and final release and stability
• Participate in manufacturing site visits and pre-approval inspection readiness initiatives
• Identify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirements
Job Requirements
- Master’s degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline (PhD preferred).
- Minimum 15 years of pharmaceutical industry experience including at least 8 years in CMC.
- Strong track record in CMC leadership across small molecule early-phase development and late-stage filing activities, including management of US and international CDMOs
- Extensive experience working with CDMOs and managing external partnerships
- In-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturing
- Demonstrated success in process development, scale-up, and validation
- Prior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets, and interacting with global health authorities (IND, IMPD, NDA, MAA)
- Strong communication, project management, and organizational skills
- Proven ability to lead cross-functional teams in a fast-paced, evolving environment
- Strong skills in identifying and resolving critical issues
- Strong track record in effectively working with senior management.
Benefits
- Health insurance
- 401(k) plan
- Company-sponsored medical, dental, vision, and life insurance
- Generous paid time off
- Health and wellness program
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