This role will serve as the lead for all Biologics Operations within the Lexington Mass Site, including Alewife, 300SW, 400SW, 200SW cell banking, & North Reading warehouse. The Site lead will have overall responsibility for delivery supply to customers according to agreed S&OP supply plans and Key Performance Indicators. Site activities are inclusive of: plant technical support, manufacturing systems, engineering support, validation execution, technical transfer receiving, manufacturing operations support functions & all direct (in site) functional support. The lead will have end to end responsibility for all production activities, full site budget control, and direct management of multi-functional teams. This will include accountability for performance management/KPI's, OE implementation, financial management, collaboration with key stakeholder functions within and outside of Tech Ops. Scope will include direct responsibility for 3 commercial biologics plants and all associated products produced therein, approximately $2 Billion in revenue, $400M in budget, about 750 employees, and a large number of late phase biological entities as well. A highly complex, dynamic, and rapidly growing operation. This is a leadership role that will need to balance strategic executive management with the ability to jump in and get to root issues to lead by example. The scope of this role requires both strong people management & leadership, and strong, comprehensive technical expertise. This is a very high impact role due to the critical nature of Rare Disease products produced within Site, and the need to ensure 100% patient supply continuity.
Leading & implementing the new Tech Ops operating model, culture & performance expectations. Build & develop strong multi-functional team to drive operations & supply performance to meet key targets.
Deliver results of production performance, finanical metrics, compliance & quality expectations to meet supply plans for all plant & warehouse operations. Develop strong partnerships with customers and other stakeholders.
Drive establishment of highly effective technical capabilities across all operations and teams, with clear focus on shop floor support & above floor technical support.
Manage and improve operations efficiency and effectiveness, deploying Tech Ops OE model and tools to drive impactful continuous improvement.
Lead and coach direct team & drive a high performance organizational culture that accommodates rapid growth & highly dynamic Shire operating expectations
Education & Experience Requirements
Strong biologics manufacturing experience (Drug Substance, Drug Product, strong exposure to biologics process development), technical understanding of multiple biologics platforms, and excellent people management expertise (Leadership & Coaching). Technical masters degree or equivalent experience required. General Technical Operations experience including clinical development, commercialization supply operations, regulatory and compliance experience, hands on technical transfer experience, direct plant management, and exposure across all Technical Operations functions.
• B.S. degree in Science or Engineering, & MBA or Masters Degree, with at least 15 years relevant biologics manufacturing leadership and management experience
• In depth technical knowledge of biologic manufacturing operations.
• Previous leadership experience with matrix cross-functional groups.
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Experience operating a multi-product manufacturing plant.
* Financial management exposure, awareness, and strong acumen.
* Ability to balance strategic awareness & direction setting with consistent tactical results.
• Previous direct management of multiple functions.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
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Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.