Senior VP Global Manufacturing Science and Technology
SVP MS&T GLOBAL OPERATIONS
The Global Head of Manufacturing, Science and Technology is a newly created position and will focus on ensuring new products introduced from R&D are designed for manufacturability and the correct internal processes are in place for a seamless hand-off between the R&D and manufacturing organizations around the globe. An experienced and strong leader is sought who can serve as a change agent and build a new team for the company. The role will lead all product transfer activities between approximately 75 global manufacturing sites as well as scale up of products from R&D into manufacturing. There are approximately 50 direct reports and 600 in total.
The successful candidate will own the monitoring of product and process parameters and will drive Product Robustness across the network; including deploying the tools and ensuring organizational capabilities are in place to meet the growth needs of the business. This position will also ensure appropriate Centers of Excellence around key technologies and functions including process engineering, packaging engineering and product strategy teams are effectively established and deployed globally.
This role will ensure technical standards are deployed globally and will work to harmonize these standards. The regional Technical Scientific Affairs (TSA) heads will report into the Global Head, in addition to functional leaders in the TSA/ Manufacturing, Science and Technology (MST) organization. The Head of MST will deploy appropriately skilled technical resources to lead hard–to-solve technical investigations and achieve speedy resolution of issues in manufacturing; will also ensure the appropriate technical depth around key technologies. The Head of Manufacturing, Science and Technology will serve as the global Operation Stage Gate approver for products going into Engineering batches as well as Submission batches, per the newly defined development business process.
The successful Head of MS&T will be expected to assess the Global Operations organization structure, processes and internal resources and be able to make decisions around what the future network should look like. An individual with a collaborative, inclusive and influential communication and leadership style with a strong global mindset is desired. The scope and breadth of technology includes: various oral solid dosage form, liquids, ointments, creams, biologics, therapeutic proteins, devices, generics, and Injectables. There is a need to create a strong alignment with the regions to ensure technical competencies are leveraged and continue alignment with R&D and across key functions
ESSENTIAL AREAS OF RESPONSIBILITY:
- Member of the COO leadership team. Participate in leadership team meetings to form strategy for executing goals and global objectives.
- Actively engage with R&D and act as the Stage Gate for products at the Engineering Batch and Submission stage of new product introductions.
- Create, promote and improve business and technical processes. Drive global standards for validation and product robustness across all the regions.
- Develop and implement a knowledge data base system to ensure that technical transfer activities are executed and summarized with appropriate results in approved reports to support regulatory filings and tech transfers.
- Establish process monitoring and improvements at commercial manufacturing facilities and at Contract Manufacturing Organizations (CMOs) using scientific/technical concepts and techniques in collaboration with Site Technical leaders.
- Review and approve proposals for improved manufacturing processes, implementation of PAT and other tools that enhance process robustness and state of process and product knowledge.
- Deliver agreed financial targets such as departmental budget and key performance indicators.
- Advanced degree in science or engineering with minimum 15 years’ experience in the pharmaceutical drug product industry is preferred; Ph.D. or other advanced degree with comparable industry experience is desired.
- Demonstrated communication skills, both verbal and written; ability to influence others and build cross-functional teams while setting clear business objectives
- Demonstrated leadership and technical experience as well as a proven track record of transferring technology and products from R&D to manufacturing.
- In-depth understanding of CMC regulatory requirements and technical risk management.
- Ability to present complex scientific information to all business audiences
- Sustained excellence in performance and accomplishments that align to company goals.
- Demonstrated competency in development of project plans (milestones, timelines, resources, etc.) for analytical and manufacturing transfers.