Senior Project Manager - Tech Transfers, Pharma
- Experience Level
Scope of Responsibilities:
This person will work with all functional leads to project manage all identified projects in the portfolio, this may include working with third party providers as necessary for each assigned project.
Specific responsibilities include:
- Define the scope of the project in collaboration with relevant functional heads
- Project management of assigned projects. This includes but is not limited to product development, technology transfer projects, process validation, clinical studies, technical support and optimization projects at external CMOs and production of clinical trial material.
- Lead proactive risk and mitigation planning to achieve project deliverables.
- Manage and develop integrated development project plans including milestones, timelines, resources and budgets.
- Execute the plan with project lead/sponsor according to agreed project plan
- Monitor the progress of the project and make adjustments as necessary to ensure the successful completion of the project
- Establish a communication schedule to update stakeholders including appropriate staff in the organization on the progress of the project
- Review the quality of the work completed with the project team on a regular basis to ensure that it meets the project standards
- Coordination and, as appropriate, authoring or reviewing of project documentation.
- Manage all team members and external CMOs for the timely execution of activities related to the assigned projects.
- Create and monitor KPIs for the team to ensure success
- Assist in launch readiness activities in close collaboration with QA, Regulatory and Supply Chain.
- + 10 years’ experience in pharmaceutical industry with prior experience in a technical function.
- Previous working in cross functional setting and with third parties.
Functional/Technical Knowledge & Skills:
- Demonstrated leadership skills in working with cross functional teams
- Solid experience in developing and implementing robust project plans for success
- Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies
- Working knowledge of project management
- Outstanding planning, communication, collaboration and influencing skills
- Excellent command of English (written and verbal)
- High working ethics and integrity
- Academic degree in Pharmacy/Chemistry, or equivalent