Director, Project Management (Pharma Manufacturing) – Top $$
Our client, a rapidly-expanding RTP-based company that is developing a highly anticipated portfolio of ophthalmologic products, is actively recruiting for an exceedingly skilled and savvy Project Management leader with particular expertise in Pharma Manufacturing to assume key role on its management team.
Company is nearing commercialization of multiple products. It is essential that top-notch people are in place to drive clinical and commercial production projects. Seek a strategic, knowledgeable and industrious candidate who will work exceedingly well in this emerging business setting. Launch experience will be important.
Key things to note:
- Position will involve directing Project Management from development to clinical/commercial manufacturing. Strong Project Management (PM) skills must be complemented by CMC expertise, deep understanding of regulatory requirements, process and practices and keen financial management skills.
- Company heavily relies upon CMOs for manufacturing. Right candidate will have extensive experience with this model, and with ensuring that 3rd party vendors effectively implement agreed-upon processes and standards.
- This is a hands-on leadership position in a highly collaborative setting. Seek candidate who is a committed developer of people and who has a history of developing positive, symbiotic relationships with all stakeholders.
This Director will be responsible for overall strategic planning and the development, oversight and effective use of project timelines, budgets and resource plans for development and manufacturing projects as well as risk assessment and mitigation. He/she will supervise a small (but growing) team.
Specific responsibilities will include:
- Lead strategic planning for the Manufacturing department, ensuring department goals are aligned with corporate objectives and translated into project-level priorities and objectives.
- Work closely with functional leaders to develop and effectively use project timelines, budgets and resource plans. Monitor project progress, track key deliverables and project milestones. Organize project review meetings.
- With project leaders, identify project risks and prepare mitigation and contingency plans. Identify upside potential and opportunities to accelerate timelines.
- Partner and work cooperatively with other internal stakeholders in Manufacturing, Quality, Regulatory, R&D and Clinical. Work to develop high-level and detailed integrated project plans; ensure resourcing and priorities are in alignment with broader corporate goals, initiatives and timelines.
- Provide project management support to key department projects, including external CROs/CMOs (project plans, meeting coordination, action tracking, etc.).
- Develop and track metrics to enhance team and department performance and communicate to management.
- Oversee annual department budget-setting process, monthly financial reviews and quarterly budget forecasts. Identify and pursue cost reduction opportunities for the department.
- Ensure adequate support of day-to-day financial transactions (purchase orders, invoices, accruals).
- Bring and foster a continuous improvement mindset.
- Develop the technical capabilities of the department. Instill use of project management tools and principles.
Ideal candidate will offer a related technical degree (advanced degree preferred) and 15+ years of increasingly responsible roles in the pharmaceutical industry with particular expertise leading Project Management and Manufacturing.
Other priorities include:
- Strong understanding of CMC development and manufacturing activities (clinical through commercial)
- Good working knowledge of current US and European pharmaceutical regulatory/compliance requirements
- Experience driving new product launches
- Extensive experience directing and overseeing CMOs
- Sound understanding of project financials; ability to develop project and department budgets, track spending and forecast future spending for a complex development and manufacturing programs
- Demonstrated ability to engage and lead cross-functional teams; Seasoned supervisory skill
- Longevity and impact in previous roles
Finally, we seek a forward-thinking quick study who will thrive in this emerging and collaborative setting; a smart and resourceful critical thinker who is both a strategist and a tactician; an innovative, process improvement-focused candidate who will have significant impact. The future is very bright. We seek a leader who will contribute and thrive.
Compensation will be generous and include an industry-leading base, bonus, benefits and stock.
Please forward Word resume for prompt consideration.