Technical Services Director
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.
The Technical Services Director will build the Technical Services program under the Commercial/Contract Manufacturing Vice President's guidance. This individual will participate in planning and execution of Myovant CMC strategies and lead all scale up and technical transfer of various API/chemical process, formulations, product and packaging technologies; serve as a SME to support product/process improvements, and build on continuous improvement of existing manufacturing efficiencies, across Myovant's product portfolio.
Essential Duties and Responsibilities
- Responsible for providing technical expertise in the selection of external manufacturing sites to ensure quality, compliance and efficiency in meeting project needs and production requirements
- Collaborate with leadership and partners in defining matrix/process for selection of clinical and commercial manufacturing sites for Relugolix and other portfolio compounds.
- Build effective and strategic technical partnership with CMOs to meet Myovant business needs. Partner with R&D Product Development on formulation, process, equipment and raw material changes.
- Provide technical assistance, expertise, and solutions when troubleshooting existing product formulations and throughout all processes while maintaining product quality and food safety.
- Manage formulation adjustments at scale once document transfer from R&D occurs; ensure that formulations are revised and updated in accordance with any operational changes (raw material swaps, equipment updates, etc.)
- Drive business process improvements related to tech transfer, operational support and technical oversight of manufacturing.
- Lead investigations to determine root cause for out of spec products or processes and defining corrective and preventive actions as related to product quality, manufacturing processes, and external testing protocols.
- Assist in review and revision of departmental SOPs to streamline and improve current practices
- Work with line manager and partner functions to develop processes/systems to effectively manage vendor selection and performance assessments
- Responsible for managing the Continuous Process Verification (CPV) Program and driving continuous improvement in all operation processes
- Experience with authoring regulatory filings of relevant sections (IND, BLA and MAA filings)
- Develop specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues
- Perform other duties as assigned
- Routine travel may be required in support of technology transfers and manufacturing oversight of CMOs
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Demonstrate coaching skill to develop team
- Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
- High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
REQUIREMENTS (Education and Experience)
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- 13+ years of progressive experience in the pharmaceutical industry with a technical focus and a BS or BA.
- Good understanding of the CMO landscape, knowledge of CMO capabilities and limitations
- Demonstrate in-depth knowledge of Good Manufacturing Practices (GMPs)
- Demonstrate in-depth knowledge of manufacturing principles, concepts, industry practices, and standards.
- Solid knowledge of regulatory requirements in the US and the EU.
- Experience in CMC technical development is preferred.
- Project management experience and/or certification is a plus.
- Demonstrated ability to work effectively in a team-oriented CMC environment
- Ability to effectively manage vendors globally
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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Equal Employment Opportunity