Director Manufacturing Science and Technology
The commercial program CMC Team Leader (Biologics MS&T and Commercial CMC Leader) is a strategic leader responsible for global CMC activities in support of programs through registration and into commercialization. The CMC lead participates in the development of the strategy and ensures the execution of an active CMC life cycle management program. Responsibilities: Lead commercial CMC team(s) and related MS&T group The commercial program CMC Team Leader (Biologics MS&T and Commercial CMC Leader) is a strategic leader responsible for global CMC activities in support of programs through registration and into commercialization. The CMC lead participates in the development of the strategy and ensures the execution of an active CMC life cycle management program.
The successful candidate will:
1. Establish and lead the cross functional CMC Team representing all TechOps line functions. Partner with all relevant functions within Shire HGT to align on strategy for a global drug supply network with optimal drug product presentation and supply in the global market.
2. Become the product and process subject matter expert within TechOps and Regulatory CMC.
3. Develop and manage technical group accountable for the holistic support of commercial drug substance and drug product manufacturing process.
4. Lead CMC strategy development, covering all aspects of the late phase and commercial program ranging from drug substance manufacturing through drug product presentations received by patients covering the following aspects:
* Stewardship of product performance and quality, included, as necessary, implementation of retrospective QbD
* Input into and translation of commercial product strategy into actionable goals for MS&T and the CMC team
* Translation of Regulatory strategy into actionable goals for the CMC team
* Oversight of IP, Regulatory, and life cycle management
* Alignment of global supply needs, including global expansion, with global manufacturing/testing and regulatory strategy
* Authorship, review, and submission of regulatory filings
* Coordination of responses to Agency requests
* Prompt action on PMCs
* Monitoring and acting promptly to address process and product quality trends & issues
* Alignment of cross-functional goals and objectives
* Identification of gaps & initiation of improvement programs
* Alignment with Franchise strategy and prioritization of goals
* Definition of strategy that includes budget and forecasts for TechOps activities associated with the product and program in the LRP.
* Evaluation & action on competitive intelligence
* Use of innovation to drive competitive advantage Education and Experience Requirements: MS/PhD in a relevant biopharmaceutical discipline with 15 years experience, in Process Development, Manufacturing, Regulatory, or a related field. Experience leading the life cycle management of manufacturing processes for commercial products is a must.
Key Skills, Abilities, and Competencies:
The Biologics MS&T and Commercial CMC Leader should have extensive experience (10+ years) leading a commercial technical organization (MS&T), CMC teams, or other related cross functional teams that require program leadership within a matrix environment. In-depth technical experience in a relevant biopharmaceutical development discipline is required. The cCMC lead should have experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, cGMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions. Demonstrated leadership and capability for strategic analysis and issue resolution, organizational and project management skills working in a matrix environment is also required. The Biologics MS&T and Commercial CMC Leader should possess excellent communication, negotiation, problem solving and decision making skills and a strong ability to influence or manage without direct authority. Highly developed interpersonal skills will be a substantial component of being successful in this demanding role. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.
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