Shire Head of Technical Services, Piercetown in Dunboyne, Ireland
The Head of Technical Services (TS) - Piercetown will oversee all technical aspects for a new drug substance manufacturing facility build in Ireland (Project Piercetown) including facility/equipment design, process development & fit, technology transfer, facility qualification and start-up, process/analytical validation and product registration. The Head of TS will also be responsible for establishing a site Technical Services function directly supporting Manufacturing Operations and product transfers. The role will be responsible for hiring, training and developing the TS function with capability for laboratory services, process installation and manufacturing floor support including quality investigations. The Head of TS Piercetown will be a member of the Piercetown project and site leadership teams and the primary point of contact between the project team and PDTS technical functions.
Define, coordinate and drive completion of technical work packages with functional representation for process/analytical development, laboratory services and process/analytical validation.
Closely coordinate technical deliverables/input to meet Project Piercetown timelines for design, facility start up, process validation and CMC product registration.
Primary technical contact with Piercetown project team, product teams, PDTS leadership/steering team and other key stakeholders including Quality and CMC Regulatory Affairs.
Joint responsibility with Tech Transfer Lead to establish and manage Tech Transfer activities with coordination across PDTS technical teams and activities.
Manage PDTS project/functional budgets and resources to complete technical work packages and routine TS operations.
Establish and manage TS Piercetown team inclusive of hiring, training and colleague development to deliver TS activities including product transfers, site start-up activities and routine manufacturing support.
Education & Experience Requirements
This individual will have a minimum of:
A BSc in Biochemistry/Protein Chemistry or Chemical Engineering or related discipline with a minimum of 10 years of relevant experience.
Technical expertise with Biologics drug substance process development and/or manufacturing operations.
Experience of bioprocess facility design and start-up
Experience leading process technology transfers for clinical/commercial biologics (s)
Experience with project management and/or leadership enabling cross functional engagement to deliver project goals and timelines.
Experience managing a technical team or function inclusive of hiring and developing high performing colleagues
Experience establishing and managing team and/or functional budgets
Experience leading global teams and/or initiatives.
Accredited six sigma and/or lean manufacturing desirable
Key Skills and Competencies
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
High level of customer orientation and organizational skills
Enthusiastic, decisive and motivating personality
Excellent verbal and written communication skills
Good understanding of drug substance manufacturing processes, GMP compliance & regulatory guidance for product registration, lifecycle management and technical transfer.
Other Job Components
Complexity and Problem Solving
Ability to develop and manage high performing teams
Ability to lead and motivate cross functional global teams
Ability to influence and communicate effectively to stakeholders & leadership
Escalate and resolve project issues/roadblocks as appropriate
Ability to identify and resolve complex technical issues including quality investigations
Internal and External Contacts
Technical Services and other PDTS Functional Groups (Product Lifecycle, CMC, QbD/Validation, Process & Analytical Development)
Product teams (TOPT/CMC)
Site Leadership team
- Require travel between Ireland/USA/Europe (20%)
Notice to Employment / Recruitment Agents:
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.