Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company
Director, CMC Program Management - Drug Product
Boston, MA · Director · Full-time
Sponsorship not specified$200k-$225kDetected 6 days ago
Project ManagementExcelSupply ChainLogisticsGMPLeadershipCommunicationCollaborationTime ManagementAdaptabilityOrganizational SkillsMicrosoft Office
About the role
- Description of Role Centessa is seeking a Director of CMC Program Management for Drug Product.
- 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.
- Work Location The Director CMC Program Management, Drug Product role is based in the US, with domestic and international travel.
Responsibilities
- 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.
- Support CMC activities including tracking relevant GMP and Regulatory documentation.
- 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.
- Experience utilizing project management tools and best practices to support CMC activities.
- Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
Requirements
- 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
- Experience coordinating and managing CDMO activities supporting development and commercialization
- 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
- BS/MS in a scientific discipline
- PhD preferred
- Thorough understanding of cGMP regulations for pharmaceutical products
- Strong project management, organizational, and prioritization skills to manage multiple, evolving programs
- Excellent decision-making, analytical, and resource management skills in dynamic, global environments
- Self-motivated, results-driven, adaptable to changing priorities, and willing to travel domestically and internationally
- Compensation
Nice to have
- 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
- Monitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnel.
- 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.
- 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.
Compensation
- The annual base salary range for this level is $200,000.00 to $225,000.00.
- Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
- In addition to base pay, this role is eligible for a discretionary annual bonus.
Benefits
- 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.
- 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.
Company info
- Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants.
- We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
- We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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