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 VP of Facilities and Engineering will lead the Capital Planning and Project Execution for a new flagship campus in King of Prussia, PA. The site is comprised of 14 buildings and over 1 million square feet of Advanced Therapies manufacturing. Reporting to the Chief Operating Officer, this individual will be responsible for the on time, and on budget completion of the construction and commissioning of the new facility. The individual will lead a team of site-based staff to assure the delivery of capital projects, manage the capital planning and budgeting, and support the continuous improvement of capital delivery business systems. Once commissioned, this individual will manage the day-to-day operation of the site for the clinical and commercial manufacture of the company s cell and gene therapy products. In this role, the individual will matrix with the company s technical operations, quality, facilities and G&A departments to recruit staff and to build and operate the infrastructure to deliver the company s products.
- Drive on time and on budget site-based capital engineering projects including responsibility for Engineering & Facility resources and aligning supporting and customer function resources to ensure the successful delivery of the new cGMP manufacturing facility.
- Matrix with the company s technical operations, quality, facilities and G&A departments to recruit appropriate staff and build the required operational infrastructure to develop, manufacture and deliver the company’s cell and gene therapy products
- Direct the Projects team providing clear, consistent leadership, management and mentoring.
- Manage the project portfolio ensuring appropriate division of work among the Project Managers and overseeing the portfolio project ensuring on scope, delivering on time and within budget.
- Provide technical expertise to internal and external customers.
- Facilitate problem-solving, contingency planning, and decision-making for the matrixed facilities, CMC, quality and supply chain teams
- Once commissioned, manage the day-to-day operations of the Discovery Labs King of Prussia site ensuring compliance with applicable international, federal, state and city regulations for product manufacture and distribution, environmental, health & safety and company policies and procedures
- Develop project objectives working with user requirement and business plans. Implement and maintain best business and operational practices.
- Collaboratively manage the site-based capital budget including the annual operating plan development; project justification; project cash flow (commitment, spend and invoice), on-going maintenance of the budget and all associated reporting.
- Prepares, owns, and maintains budgets for the Discovery Labs capital portfolio.
- Reports on portfolio performance for site leadership.
- Drive continuous improvement into the engineering execution lifecycle to reduce total overall cost while improving efficiency.
- Identify and report on lessons learned after the project close-out.
- Drive operational excellence and continuous improvement.
- Provide engineering input if required into the site Validation Master Plan and assist with maintaining all relevant equipment in a validated state.
- Bachelor of Science degree in Engineering or similar with a minimum 15 years of experience in management of facilities, engineering or related field or equivalent experience. Advanced degree such as an MBA would be an advantage.
- Deep knowledge of facility infrastructure and operations including GMP production area support in biotech/biopharma industry, business management, and construction management
- Demonstrated ability to work and collaborate on cross functional teams (e.g. Research & Development, Manufacturing) in a fast paced, dynamic team
- Strong interpersonal and excellent verbal and written communication skills are essential
- A “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Working knowledge of principles and practices of project management, business administration, procurement, contracts, financial principles and practices
- Knowledgeable of health, safety and environmental regulations, FDA and similar cGMPs.
- Strong knowledge of architectural finishes and components
- Planning, problem analysis, and decision-making skills
- Proficient computer skill utilizing MS Office suite applications, Building Management
Systems, and Computerized Maintenance Management Systems (CMMS)
- Customer service focused
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility