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).
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
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 collab
Benefits
Flexible schedule
Additional Information
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
Description of Role
Centessa is seeking a Director of CMC Program Management for Drug Product. 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. The 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. Travel to vendors both domestically and internationally will be required.
Centessapharmaceuticalsinc · Boston, MA