Shire Head of Technical Services, Piercetown in Dunboyne, Ireland

Job Summary

Primary Role

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.

Essential 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:

Leadership Behaviors

  • Be Positive

  • Be Accountable

  • 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)

  • Manufacturing Operations

  • Supply Chain

  • Quality

  • Regulatory Affairs

  • Site Leadership team

  • CMO labs

Other Requirements

  • Require travel between Ireland/USA/Europe (20%)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.