Centessa Pharmaceuticals · 2 weeks ago
Executive Director, CMC
United States
Full-time
Remote
Director/Executive
$285K/yr - $370K/yr
15+ years expCentessa Pharmaceuticals is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision making. They are seeking an Executive Director of CMC to lead small molecule development programs across all CMC functions, driving technical strategies and managing outsourced manufacturing partnerships.
BiotechnologyPharmaceutical
Responsibilities
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
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
Qualification
Required
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
Master's degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline
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
Preferred
PhD in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline
Benefits
Discretionary annual bonus
Participation in our equity program
401(k) plan
Company-sponsored medical, dental, vision, and life insurance
Generous paid time off
Health and wellness program
Company
Centessa Pharmaceuticals
Centessa Pharmaceuticals is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process.
51-200 employees
H1B Sponsorship
Centessa Pharmaceuticals 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 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.12BKey Investors
Oberland CapitalGeneral Atlantic,Janus Henderson Investors,Vida Ventures
2025-11-11Post Ipo Equity· $250M
2024-09-11Post Ipo Equity· $225M
2024-04-23Post Ipo Equity· $100M
Leadership Team
John Crowley
Chief Financial Officer
Gregory Weinhoff
Chief Business Officer
Recent News
BioWorld Financial Watch
2026-01-22
2026-01-05
Company data provided by crunchbase