Reporting to the Sr. Manager of Process Development, you will lead New Product Introduction (NPI) and lifecycle management projects for Drug Product (DP) and Finished Drug Product (FDP). You will be responsible for driving cross-functional teams to ensure the successful delivery of high-quality pharmaceutical products. This is a 12 month hourly rate contract.
- Key Responsibilities
- Project Leadership: Develop and manage end-to-end project plans, including scope, schedule, budget, and resource allocation.
- Cross-Functional Collaboration: Lead site SMEs, managers, and global functions to ensure smooth product transitions and operational health.
- Risk & Change Management: Proactively identify risks and mitigation pathways. Own the GMP change control process and maintain action/decision logs.
- Communication: Act as the primary liaison between stakeholders, ensuring alignment on goals and project progress.
- Compliance: Maintain strict adherence to cGMP, safety standards, and financial guidance.
- Required Qualifications & Experience
- Education: Technical Degree or Master's in a relevant field.
- Experience: 5-8 years in the Life Science/Biotech industry, including a minimum of 3 years specifically in Project Management.
- Soft Skills: Strong ability to influence, resolve conflicts, and lead multinational teams.
- Technical Proficiency: Expertise in Smartsheet, MS Project, and Trackwise (or similar Change Control systems).
- Experience in Portfolio Resource Management and Business Case Development.
- A proven track record of continuous improvement and problem-solving in a manufacturing environment.
