Associate Director, TS/MS Manufacturing CMC Project Management

Role Summary

Associate Director, TS/MS Manufacturing CMC Project Management leads cross-functional teams to integrate Manufacturing CMC elements for molecule commercialization. Develops and implements an integrated technical plan for commercially manufactured molecules. Coordinates Global Product Assessments and applies project management principles to drive safe, high-quality manufacturing across the lifecycle. Location: Indianapolis, IN. Travel: Some travel may be required (<5%).

Responsibilities

• Team Leadership
  • 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.
• Project Management Leadership
  • 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.
• Governance Facilitation and Reporting
  • 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.
• Functional Leadership
  • Mentorship of peers and team members.
  • Support process improvement.
  • Subject Matter Expert of a process or system.

Qualifications

• Required: Minimum 5 to 10 years’ experience in more than one Pharmaceutical Development CM&C function OR Pharmaceutical Manufacturing function/site
• Required: Demonstrated leadership of cross-functional teams
• Required: Demonstrated project management experience
• Required: Demonstrated knowledge of CM&C aspects of Commercialization and Commercial Manufacturing
• Required: Strong interpersonal and teamwork skills
• Required: Strong oral and written communication skills
• Required: Strong problem-solving skills, self-management and organizational skills

Education

• BSc or MSc in Chemistry, Biology, Engineering or equivalent Scientific degree.

Skills

• Cross-functional collaboration
• Leadership
• Communication

Additional Requirements

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