Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Director, CMC Program Management - Drug Substance

Boston, MA · Director

Sponsorship not specifiedDetected 12 days ago
Project ManagementExcelSupply ChainLogisticsGMPLeadershipCommunicationCollaborationTime ManagementOrganizational SkillsMicrosoft Office

About the role

  • Description of Role Centessa is seeking a Director of CMC Program Management for Drug Substance.

Responsibilities

  • Partner closely with the CMC project lead to devise project strategic goals and drive these through seamless tactical execution.
  • 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.
  • In collaborations with the CMC lead, 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 relevant pharmaceutical industry experience, including 7+ years leading CMC project/program management activities
  • BS/MS in a scientific discipline
  • PhD preferred.
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Nice to have

  • Serve as a 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.

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.
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