Head of Contract Manufacturing CoE (Senior Director level)
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POST DATE 9/16/2016
END DATE 11/2/2016
JOB DESCRIPTIONAPPLY Job Description
The Head of Contract Manufacturing in the Small Molecule Operating Unit is responsible for the development and maintenance of Shires outsourcing model and outsourcing capabilities across Technical Operations.
This position will Chair the Contract Manufacturing Center of Excellence (CoE) responsible for developing common best practices to manage external partnerships and the Community of Practice (CoP) to drive continuous improvement of the model in partnership with the CMOs.
This position manages a total team of up to five (5) direct reports (no indirect).
Partners with Head of the Small Molecule Operating Unit to create alignment across Tech Ops around a proven set of outsourcing best practices through the creation and maintenance of a CoE and a community of practice for Tech Ops covering the Small Molecule, Plasma Products and Biologics Operating Units, Packaging and PD (20%)
Drives the deployment of the outsourcing model across Tech Ops with as much standardization as serves the effectiveness and efficiency of Tech Ops (20%)
Supports the deployment of the model to CDMO, CMO, CRO, and Contract Laboratory Partners (20%)
Develops and Deploys a Governance Process for Outsourced Relationships that is both standardized in philosophy and fit for purpose in magnitude relative to the size and importance of the relationship (20%)
Ownership of the Continuous Development and Improvement of the Best Practices in Outsourcing to maintain outsourcing as a sustainable competitive advantage for Shire. Builds B2B partnerships / relationships and ensures quality, cost, service performance and supply availability in assigned product categories. (10%)
Leads and coaches teams (mentoring Supplier Relationships and Manufacturing Leads) (10%)
o Coordinates the CoE and broader CoP activities across Tech Ops
o Ensures a common understanding of the current Best Practices and ensure that they are documented and deployed through training and process implementation
o Develops and executes scorecard and metric processes and maintain those processes to enable timely and regular review, discussion, and action by Operating Units and Functions to drive results and continuous improvement
o Benchmark Best Practices in Outsourcing for our industry and other industries and through the CoE, CoP and Strategic Partners drive the further development of the Shire model
o Hold regular 1:1s with SR&M leads to provide mentoring and to gain feedback on the performance of the Shire model
o Regularly attend Governance meetings with partners supporting each Operating Unit and Function to understand the health of the relationship and the challenges being addressed.
o Provide direct support as required to ensure supply and the resolution of challenges within the within the outsourced environment for Tech Ops
EDUCATION & EXPERIENCE REQUIREMENTS
Essential: B.S. degree in Science or Engineering or related field, with at least 20 years relevant pharmaceutical industry experience. Previous experience managing significant third party, CMO, external manufacturing partner relationships. General Tech Ops experience including clinical development, commercialization supply operations, regulatory and compliance experience, and exposure across all Tech Ops functions.
Desired: Master s degree.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
EQUAL EMPLOYMENT OPPORTUNITY
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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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.