There is a life sciences revolution occurring being driven by the tremendous demand for cell and gene therapies. This demand coupled with the desire for collaboration, the availability of capital, regulatory mind shifts, technological developments, and bottlenecks in supply chains are creating tremendous opportunities for first movers and service providers. The Discovery Labs platform supports and drives this new environment by creating space for CGT Manufacturing, Research and Discovery and the all supporting services.
The Senior Program Manager will coordinate and drive the execution of all stages of client programs from initiation of the partnership, process development, technology transfer, and cGMP manufacturing. Program managers will be responsible for successful completion of client programs on timeline and within budget. The position requires a highly motivated individual able to progress programs forward in a matrix team environment and serve as the client’s advocate within the CDMO (Contract Development and Manufacturing Organization) business. Candidates must have demonstrated success managing complex programs within the Pharmaceutical industry, preferable for large molecule products. In addition, they must be able to drive programs forward and work collaboratively with both clients and colleagues in an environment that requires collaborative decision making.
• Be results-driven and reliably meet and exceed customer expectations by supporting the program needs of CDMO partners and clients.
• Oversee all stages of projects within a matrix organization. Specifically, this includes the introduction of new products into the facility, supporting process development, analytical development, technology transfer of new products to cGMP manufacturing through all stages of clinical development through to commercial.
• Effectively resolve project team issues and facilitate decision making within the team even in conflict situations.
• Track and manage the financial aspects of the project including milestone payments, pass through costs and FTE estimates to ensure client programs progress on time and on budget.
• Manage progress, issues, and risks of programs of substantial complexity and scale.
• Responsible for supervision during the initiation, planning, performance, monitoring, and conclusion of projects at the Program Team level.
• Communicate regularly with business, technical and customer teams. Track and report on critical program milestones.
• Develop, improve, and implement program and project management tools and templates for use by the program teams. Demonstrate role model leadership in the execution of PM standard work and customer-centric behavior.
• Support department and individual goals and key performance indicators in alignment with the Center for Breakthrough Medicines operational and organizational goals.
• Manage all client interactions, including maintaining and a regular cadence of project meetings, preparing meeting minutes, maintaining an action tracker, and effectively following up with internal and external team members to progress the program and closeout of actions.
• Ensure efficient and effective communications of program/project related information to all levels within the organization and to clients.
Education & Experience
• Bachelor’s Degree in a relevant scientific discipline. (Graduate degree is a plus).
• Certification strongly preferred (PMP, Six Sigma, or equivalent).
• Minimum 5-8 years related experience in the pharmaceutical industry, with experience in biopharmaceutical manufacturing strongly preferred and in CDMO highly valuable. Possess working knowledge of pharmaceutical and biopharmaceutical product lifecycles with experience managing process development and/or clinical or commercial manufacturing programs.
• 1-5 years’ experience in a project or program management role responsible for customer or internal programs (experience in a contract manufacturing organization is a plus) and a strong understanding of CMC.
• Equivalent combinations of education, training, and relevant work experience will be considered.
• Significant experience leading cross-functional teams to deliver on-time and on-quality.
• Knowledge of cGMPs, regulatory environment, and biopharmaceutical manufacturing.
• Ability to adapt and manage conflict in a constantly evolving environment.
• Must have exemplary interpersonal skills; should be an effective leader who can manage and lead in a matrix environment while maintaining order and a larger picture perspective.
• Ability to break down complex scenarios and situations into clear and concise points.
• Self-motivated with a strong sense of ownership in areas of responsibility.
• Strong planning, problem analysis, and decision-making skills.
• Demonstrated success in organizational and time management skills to deliver projects meeting all stakeholder expectations.
• Demonstrated expertise in project management including timeline and budget management, communication plans, proactive risk prevention, action tracking and project plans. Experience implementing new tools and business processes to support department efficiency.
• Expert with MS Project, MS Excel, MS PowerPoint and MS Word.
• Adhere to policies and procedures and ensure a safe and healthy workplace environment.