Vertex has installed a state of the art Good Manufacturing Practices (GMP) manufacturing facility in Boston at the Vertex Manufacturing Center (VMC), less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical to commercialization. This GMP facility encompasses drug substance and drug product manufacturing, as well as an analytical Quality Control (QC) release and stability laboratory, spanning early development to commercial manufacture. The site also houses the first FDA and EMA approved fully continuous drug product manufacturing rig, the Development and Launch Rig (DLR).
Vertex strives to be industry leading in the rapid development and commercialization of breakthrough medicines enabled by advanced manufacturing and analytical technologies, and the VMC is a key component of this strategy. As such, the next VMC Site Head leader will be excited by and driven to deliver fast, nimble technologies which enable us to continuously improve our manufacturing capabilities and implement strategic innovations to enable this (for example, electronic batch records).
Responsibility for the efficient and compliant functioning of the manufacturing site, including direct responsibility for the API and drug product manufacturing functions, materials management, validation and the release and stability (RSL) QC analytical laboratory.
Scheduling, planning, and tracking all activities as well as the coordination of partner functions including Quality Assurance, Facility Operations, Environmental Health and Safety, Pharmaceutical Operations, Supply Chain and all corporate functions.
Leads a team of cross functional stakeholders to drive strategic decisions into manufacturing execution
Facilitating alignment and appropriate prioritization between product development and manufacturing priorities at the site.
Establishing and communicating a site mission and the strategic direction, business goals, objectives, and priorities.
Fostering a culture of flexibility, nimbleness, efficiency and a strong compliance mindset while promoting positive collaboration among all team members, partners and key stakeholders.
Ensuring products are developed, manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, EMEA, and Rest of World (ROW) regulatory requirements.
Analysis of operating costs and driving towards efficiency improvement
Attracting and developing top talent.
15+ years progressive experience in a key leadership/management role in pharmaceutical development and manufacturing
Deep understanding of the science and technology underlying continuous and batch pharmaceutical manufacturing as well as analytical techniques that support manufacturing activities
Demonstrated understanding of the principles and applications associated with manufacturing operations, maintenance and engineering
Previous experience leading manufacturing site operations (ideally with small molecule) from development through commercial
Strong knowledge of cGMP requirements
Previous leadership experience working in a highly matrixed environment, with a proven track record of building successful relationships across departments and multi-disciplinary functions
A flexible style which fosters the rigidity of management of a GMP facility compliantly while remaining flexible to the competing demands of our programs
Must understand the needs of key collaborators and customers, and interact effectively intra- and interdepartmentally to achieve alignment and consensus
Outstanding interpersonal, verbal, written and presentation skills
Excellent planning and organizational skills, with the ability to balance production, development and maintenance needs
Strong understanding of budgeting/expense management with a basic understanding of financial and accounting practices
Track record of attracting, developing, inspiring and retaining key talent
Demonstrated ability to create and implement a vision for an organization
Must possess excellent team management skills
Proven track record successfully managing regulatory inspections
Track record of managing and influencing at a senior level
Vertex Pharmaceuticals, Inc