Director, CMC Program Management - Drug Product

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

• 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 required

• 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 annual base salary range for this level is $210,000.00 to $240,000.00. 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 Director CMC Program Management, Drug Product role is based in the US, with domestic and international travel. POSITION: Full-Time, Exempt

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.