Description of Role

Centessa’s CMC group is seeking a Senior Director of Analytical Development within the CMC group. The successful candidate will have hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development. T 

Reporting to the VP, CMC, the Senior Director will drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross-functionally with drug substance and drug product teams across programs.  Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount.   

This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines.  Travel to vendors both domestically and internationally will be required. 

Key Responsibilities

• Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs
• Collaboratively work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors including method implementation, qualification/validation, and transfer in support of pre-IND through Registrational programs
• Review method validation protocol and reports, and test data for release, stability, and characterization
• Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments
• Lead specification settings based upon batch history and supporting analytical data
• Act as the CMC team analytical representative member in program development teams  
• Act as role model and subject matter expert for junior analytical scientists
• Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, discriminatory and quality control dissolution method development, and structural elucidations
• Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA, etc) as well as responses to Regulatory requests for information
• Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting
• Active participation in batch record review 

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, or related field (minimum BS/MS required; PhD strongly preferred) with 15+ years of small molecule pharmaceutical industry experience
• Extensive experience in late phase analytical development of small molecule oral solid dosage forms
• Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products
• Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities (e.g., genotoxic, nitrosamines), and forced degradation mechanisms
• Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution
• Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs
• Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation)
• Strong understanding of product quality attributes and control strategies for small molecule synthetic processes
• Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization
• Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments
• Strong analytical planning, resource management, and budget oversight skills across global CDMO networks
• Effective decision-maker and communicator, able to work independently while collaborating across functions and organizational levels 

Compensation 

The annual base salary range for this position is $240,000.00 to $290,000.00. 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. 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. 

Work Location

The Senior Director, Analytical Development, CMC (Small Molecule) role is based in the US, with travel. 

POSITION: Full-Time, Exempt

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 strongly preferred).
• Minimum 18 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 job level is $300,000 - $340,000. 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. 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

Description of Role

Centessa is seeking a short-term, contract Program Manager within the CMC group. The CMC PM will provide leadership and operational support to the development and manufacturing of our small molecule programs and actively engage with internal teams and external contract manufacturing organizations. Reporting to the Vice President, CMC, this individual will drive effective execution of CMC deliverables by the project teams in coordination with and support of program and corporate goals.  The ideal candidate should be highly organized and an exceptional communicator with experience leading early phase pre-IND teams through late-stage CMC Registration/Commercial validation and launch activities.

Key Responsibilities

• Serve as the main point of contact for all CMC project-related communications especially focused on drug product development, manufacturing, release, packaging, labeling, and stability coordination
• Foster strong relationships with internal teams, and external partners including CDMOs.
• Participate in regular telecon meetings with CDMOs to maintain the business relationship, progress, meeting notes and action items.
• Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel.
• Support CMC activities including tracking relevant GMP and Regulatory documentation.
• Interfaces with drug substance, drug product, analytical, non-clinical, clinical, Regulatory, supply chain, and Quality colleagues to ensure all projects are delivered on time, within scope and budget.
• Work with CMC team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth and/or company timelines.
• Cover all other project management requirements including shipment/logistics coordination, inventory, and production planning.
• Drive the development and management of detailed and integrated development plans for CMC projects that account for all phases of drug development across functions with timelines, work plans including interdependencies, gating items, budget, and risk management strategies.
• Oversee the delivery of project objectives per the program strategy, with a strong focus on meeting critical milestones, and managing scope changes while integrating project constraints.
• Facilitate effective collaboration across CMC functional teams, ensuring alignment on project goals and priorities.
• Communicate project updates consistently to various stakeholders, about strategy, adjustments, and development progress.
• Experience utilizing project management tools and best practices to support CMC activities.
• Excellent attention to detail, communication, time management, organizational skills, and flexible attitude to work assignments and new learning with proven ability to interact in a team environment.
• Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
• Project management professional (PMP) certification preferred.
• Expert MS Office skills including Excel, PowerPoint, MS Project, and other PM timeline software (e.g. Smartsheet).

Qualifications

• Bachelor's degree in scientific or related field; advanced degree in a scientific discipline preferred. 
• 10+ years of pharmaceutical industry experience, including 7+ years leading CMC project/program management activities
• Proven experience in small molecule drug development, with emphasis on drug product development and manufacturing
• Strong understanding of the end-to-end drug development process, including CMC, non-clinical, clinical, and regulatory activities
• Demonstrated knowledge of CMC requirements across all phases of clinical development
• Thorough understanding of cGMP regulations for pharmaceutical products
• Experience coordinating and managing CDMO activities supporting development and commercialization
• Strong project management, organizational, and prioritization skills to manage multiple, evolving programs
• Excellent decision-making, analytical, and resource management skills in dynamic, global environments
• Effective communicator with the ability to clearly convey complex scientific information both verbally and in writing
• Ability to work independently while collaborating cross-functionally and with stakeholders at all organizational levels
• Self-motivated, results-driven, adaptable to changing priorities, and willing to travel domestically and internationally

Compensation

The hourly range for this position is $90.00 to $120.00 per hour. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

Contractors engaged through Centessa are employed through a third-party agency that serves as the employer of record and provides access to a comprehensive benefits package. Eligible contractors may enroll in medical plans, including PPO and EPO options, as well as dental and vision coverage after 30 days. Additional perks, such as a 401(k), wellness programs, and other discounts, may also be available to eligible contractors. 

Work Location

The CMC Program Manager role is a remote role based in the US.

POSITION: Temporary, Non-Exempt