Associate Director, TS/MS Manufacturing CMC Project Management
Eli Lilly and Company
2 months ago
Remote friendly (Indianapolis, IN)
United States
$117,000 - $171,600 USD yearly
Operations
Position Brand Description
This role integrates Manufacturing CMC elements to support molecule commercialization and manages development/implementation of an integrated technical plan for commercially manufactured molecules. Leads cross-functional teams to deliver integrated and innovative CMC plans across the Manufacturing Life Cycle (safety first, quality always). Coordinates Global Product Assessment (GPA) for supported molecule(s). Applies Project Management principles, provides decision-making leadership, and supports process improvement within Manufacturing.
Key Objectives/Deliverables
Team Leadership
- Lead Development and Manufacturing (central and site) teams through development and execution of project plans.
- Support Development CM&C teams with strategies and operational plans to deliver required materials (e.g., API, drug product formulations, registration stability lots, clinical trial materials).
- Influence Development Manufacturing Technical Agenda and pre-submission deliverables for transition to downstream Manufacturing.
- Develop and manage an integrated Post-Launch Technical Agenda to support launch/commercial needs, reliable supply, and productivity objectives.
- Integrate the team plan to achieve Life Cycle Management objectives.
Project Management Leadership
- Deliver project milestones on time and within scope using project management approaches/tools.
- Document decisions; keep project management systems up to date.
- Lead risk assessments and contingency planning; resolve issues with Manufacturing priorities in mind.
- Ensure stakeholder alignment; support upward and cross-functional communications.
- Track leading indicators toward major milestones; build/maintain effective teams (motivate, recognize, coach/mentor).
Governance Facilitation and Reporting
- Facilitate Manufacturing Reviews and governance alignment.
- Report status, metrics, and risk; escalate as necessary.
- Coordinate GPAs with Technical Stewards and Manufacturing sites to review control and capability of manufacturing processes.
Functional Leadership
- Mentor peers/team members; support process improvement.
- Serve as Subject Matter Expert of a process or system.
Basic Requirements
- 5–10 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.
- Knowledge of CM&C aspects of Commercialization and Commercial Manufacturing.
- Strong interpersonal/teamwork skills.
- Strong oral and written communication skills.
- Strong problem-solving, self-management, and organizational skills.
- BSc required. MSc in Chemistry, Biology, Engineering, Project Management, or MBA preferred.
Additional Preferences
- Knowledge of CM&C aspects of Pharmaceutical Drug Development.
- Experience in Technical Services/Manufacturing Services, Manufacturing Operations, and/or QA/QC in Pharmaceutical Manufacturing (highly desirable).
- Smartsheet experience.
- Master’s in project management, PMP certification, or MBA preferred.
Other Information
- Some travel may be required (<5%).
This role integrates Manufacturing CMC elements to support molecule commercialization and manages development/implementation of an integrated technical plan for commercially manufactured molecules. Leads cross-functional teams to deliver integrated and innovative CMC plans across the Manufacturing Life Cycle (safety first, quality always). Coordinates Global Product Assessment (GPA) for supported molecule(s). Applies Project Management principles, provides decision-making leadership, and supports process improvement within Manufacturing.
Key Objectives/Deliverables
Team Leadership
- Lead Development and Manufacturing (central and site) teams through development and execution of project plans.
- Support Development CM&C teams with strategies and operational plans to deliver required materials (e.g., API, drug product formulations, registration stability lots, clinical trial materials).
- Influence Development Manufacturing Technical Agenda and pre-submission deliverables for transition to downstream Manufacturing.
- Develop and manage an integrated Post-Launch Technical Agenda to support launch/commercial needs, reliable supply, and productivity objectives.
- Integrate the team plan to achieve Life Cycle Management objectives.
Project Management Leadership
- Deliver project milestones on time and within scope using project management approaches/tools.
- Document decisions; keep project management systems up to date.
- Lead risk assessments and contingency planning; resolve issues with Manufacturing priorities in mind.
- Ensure stakeholder alignment; support upward and cross-functional communications.
- Track leading indicators toward major milestones; build/maintain effective teams (motivate, recognize, coach/mentor).
Governance Facilitation and Reporting
- Facilitate Manufacturing Reviews and governance alignment.
- Report status, metrics, and risk; escalate as necessary.
- Coordinate GPAs with Technical Stewards and Manufacturing sites to review control and capability of manufacturing processes.
Functional Leadership
- Mentor peers/team members; support process improvement.
- Serve as Subject Matter Expert of a process or system.
Basic Requirements
- 5–10 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.
- Knowledge of CM&C aspects of Commercialization and Commercial Manufacturing.
- Strong interpersonal/teamwork skills.
- Strong oral and written communication skills.
- Strong problem-solving, self-management, and organizational skills.
- BSc required. MSc in Chemistry, Biology, Engineering, Project Management, or MBA preferred.
Additional Preferences
- Knowledge of CM&C aspects of Pharmaceutical Drug Development.
- Experience in Technical Services/Manufacturing Services, Manufacturing Operations, and/or QA/QC in Pharmaceutical Manufacturing (highly desirable).
- Smartsheet experience.
- Master’s in project management, PMP certification, or MBA preferred.
Other Information
- Some travel may be required (<5%).