This role will be responsible for the planning, implementation, execution, and management of Chemistry Manufacturing and Controls (CMC) projects within Technical Operations. The incumbent will leverage his/her talents and capabilities to drive project services and deliverables for a rapidly growing biotechnology company. The Project Coordinator will report to the Head of CMC Management. Establishing strong working relationships within Technical Operations (e.g., Product Development, Manufacturing, Supply Chain, and Quality), the Project Coordinator will manage cross functional teams as a key individual contributor and serve as the lead point person in generating project timelines, managing day-to-day product development operations, master scheduling, and be responsible for project risk identification. In summary, the role is being created to advance early stage drug development candidates using platform manufacturing processes that require detailed project schedules while balancing resources to ensure successful development of Candidate-In-Phase (CIP) products for non-clinical testing.
Essential Functions and Duties
The candidate will manage a cross functional team within Technical Operations that will be responsible for the execution and delivery of plasmids and viral vector products to the Research and Development (R&D) organization. The candidate must have solid project management skills; knowledge on initiating processes, planning processes, executing processes, monitoring & control processes, and closing processes to appropriately address project timelines, budgets, and project scope. The role of the Project Coordinator will be forward facing to ensure that ongoing communication is provided across teams and key stakeholders within R&D and other leadership positions. The candidate must possess strong communications skills, work closely with subject matter experts, and will be accountable for the team’s overall performance.
Skills and Experience
- A Bachelor of Science (BS) in a Scientific, Engineering or Technical field, plus 2-4 years of experience in a Pharmaceutical and/or Biotechnology environment
- General project management knowledge of concepts and tools; Project Management Professional (PMP) Certificate preferred
- Proven ability to lead technical cross-functional teams, excellent people management skills
- Knowledge of Technology Transfers, cGMP Manufacturing, and Supply Chain Management
- Experience with MS Project, Excel, Word, Outlook, PowerPoint, & SharePoint
- Knowledge of product development stages (i.e., early and late)
- Experience in providing business and technical leadership for various work streams and major development projects within Technical Operations
- Ability to identify risks, schedule variances, and cost variances for major projects and escalate issues or project delays to the management team
Interested candidates should forward a cover letter and resume / CV to email@example.com