Job Title: Associate Director, Program Management, CMC
Job Number: 24154
Location: Lexington, MA
We are seeking a highly motivated and experienced individual to join our team as an Associate Director, Program Management. The successful candidate will report to the Senior Director of Program Management and will be an integral part of the Program Management and Technical Operations teams. This position offers opportunities to work with multiple external CROs, CTOs and CMOs and external partners.
- Manage CMC aspects of collaboration projects with external partners. Organize and facilitate regularly scheduled meetings, including issuance of meeting agendas, minutes etc. Control and track information exchange with external partners. Drive achievement of agreed deliverables and timelines among internal multi-disciplinary team.
- Manage internal CMC/Tech Ops Manufacturing Readiness Team. Collaborate with multi-disciplinary team members to develop integrated project plan and lead regular meetings to track activities, monitor progress, drive decision making, resolve issues, and identify risks and mitigation plans. Facilitate communication among team members and coordinate activities to drive project execution in alignment with defined schedule.
- Manage projects outsourced to multiple CROs / CTOs / CMOs. Assist with preparation of RFPs and drive contract development, review and approval. Collaborate with internal and external teams to plan activities/deliverables and establish timelines, monitor progress, drive decision making, resolve issues, and identify risks and mitigation plans. Align with internal team members to ensure completion of deliverables supporting manufacturing campaigns. Ensure integration of activities into overarching project plan.
- Proactively manage complex raw material supply chain for drug substance and drug product production. Coordinate with multiple vendors to order required raw materials and monitor outstanding deliveries. Develop long term supply chain forecast aligned with CMC production forecasts to ensure maintenance of reagent supply and identify / mitigate pinch points.
- Develop project/program budgets and manage spending against established budget.
- Bachelor’s or Master’s degree in life sciences, biotechnology or engineering with expertise in program or project management.
- 8+ years (Bachelor’s) / 5+ years (Master’s) experience in a similar position, 5-10 total years’ experience in the biotechnology / pharmaceutical industry.
- Demonstrated success in managing multiple projects effectively. Excellent organizational skills with great attention to detail.
- Strong interpersonal skills, self-awareness and ability to manage team dynamics.
- Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
- Ability to effectively represent the Company to external partners, CROs, CTOs and CMOs.
- Experience with planning and managing CMO aspects of biopharmaceutical CMC development. Results oriented and demonstrates a focus on getting (business) results.
- Excellent knowledge with all aspects of MS Office including Visio and MS Project.
- Excellent communication skills and ability to provide clear, candid, and transparent descriptions of CMC/technical tasks, issues, schedule challenges, and proposed solutions.
- Able to achieve goals in a timely manner, despite obstacles, by prioritizing tasks and building in contingency planning.
- Experience with analytical method development and qualification, process development, and cGMP manufacturing and release.