Associate Director, TS​/MS Manufacturing CMC Project Management

Position Brand Description

This role is responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the development and implementation of an integrated technical plan for commercially manufactured molecules. This position leads a cross‑functional team to ensure integrated and innovative CMC plans that accelerate life‑changing medicines to patients throughout the Manufacturing Life Cycle with safety first and quality always. The role is also responsible for coordinating the Global Product Assessment (GPA) for the molecule(s) it supports.

A person in this position will focus on CM&C, apply Project Management principles, provide decision‑making leadership for a cross‑functional team, and participate in process improvement activities within Manufacturing.

• Responsible for leading a Development and Manufacturing (central and site) team of moderate to high complexity and scope through development and execution of project plans that deliver strategic and operational objectives.
• Support the Development CM&C teams in developing strategies and implementing operational plans to deliver required materials (such as API, drug product formulations, registration stability lots, clinical trial materials, etc.) as needed to support a particular project.
• Influence Development Manufacturing Technical Agenda and pre‑submission deliverables to enable effective transition to downstream Manufacturing plan/deliverables.
• Develop and manage an integrated Post Launch Technical Agenda for assigned molecules to support launch/commercial needs, reliable supply and productivity objectives.
• Responsible for the integration of the team plan to achieve Life Cycle Management objectives.

• Responsible for delivery of project milestones on time and within scope through the utilization of project management approaches and tools.
• Document key team information and decisions and ensure project management systems are up to date.
• Encourage appropriate risk taking within the team by leading risk assessments and contingency planning at the team level.
• Resolve team issues with Manufacturing priorities in mind.
• Ensure strategic alignment with key stakeholders.
• Support upward and cross‑functional communications.
• Actively track leading indicators of teams’ progress to major milestones.
• Build and maintain effective teams: motivate, recognize, coach & mentor team members and associates.
• Gain and share learning and optimized practices within and across teams.

• Responsible for facilitating Manufacturing Reviews and other governance alignment.
• Ensure reporting of project status, metrics, and risk. Escalate as necessary.
• Coordinate Global Product Assessments (GPAs), with Technical Stewards and Manufacturing sites, to ensure holistic review of control and capability of the manufacturing processes.

• Mentorship of peers and team members.
• Support process improvement.
• Subject Matter Expert of a process or system.

• Minimum 5 to 10 years’ experience in more than one Pharmaceutical Development CM&C function OR Pharmaceutical Manufacturing function/site.
• Demonstrated leadership of cross‑functional teams.
• Demonstrated project management experience.
• Demonstrated knowledge of CM&C aspects of Commercialization and Commercial Manufacturing.
• Strong interpersonal and teamwork skills.
• Strong oral and written communication skills.
• Strong problem‑solving skills, self‑management and organizational skills.
• BSc required. MSc in Chemistry, Biology, Engineering, Project Management, or MBA preferred.

• Demonstrated knowledge of CM&C aspects of Pharmaceutical Drug Development.
• Experience in Technical Services/Manufacturing Services, Manufacturing Operations, and/or QA/QC within Pharmaceutical Manufacturing highly desirable.
• Experience with Smartsheet as a Project Management tool.
• Master’s in project management, PMP Certification, or MBA preferred.

• Some travel (domestic and international) may be required. Less than 5%.

Actual compensation will depend on a…