Executive Director, CMC

SUMMARY:

Centessa continues to expand its CMC group and currently seeks an Executive Director of CMC, to lead our small molecule development programs across all CMC functions. This individual will be responsible for driving technical strategies, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development from early-to late-stage development and clinical studies. This high-impact leadership role requires a blend of scientific expertise, operational savvy, business acumen, technical efficiency, and strategic foresight. The ideal candidate brings deep experience in small molecule drug development, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment.

The Executive Director, CMC will report directly to the SVP, CMC and will have ownership across the CMC function to include strategy, direct reports, team management, cross-functional leadership, and external manufacturing on our pipeline programs. Travel to vendors both domestically and internationally will be required.

RESPONSIBILITIES:

Strategic Leadership

• 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

Operational Oversight

• 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

Manufacturing and Technical Execution

• 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

Regulatory Affairs

• Collaborate with Regulatory Affairs to support the preparation and submission of CMC sections (INDs, IMPDs, NDAs, etc)
• Address CMC-related and pertinent cross-functional questions from regulatory authorities and ensure submission and response timelines are met

QUALIFICATIONS:

• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, interpersonal, leadership, and decision-making skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects and competing priorities
• Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Strong experience with chemical and physical characterization of small molecules
• Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
• Understanding of product quality attributes control strategies as applied to small molecule synthetic processes

EXPERIENCE:

• 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

 

Compensation

The annual base salary range for this position is $285,000 - $370,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.

Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

 

POSITION: Full-Time, Exempt, Flexibility for Remote Work