Shire MS&T Material Management Lead in Dunboyne, Ireland
This role will involve being a part of the Manufacturing Science and Technology Team for our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
The MS&T Material Management Lead is responsible to manage all material qualification activities within Manufacturing Science and Technology on behalf of the Dunboyne site. This position will act as the lead contact with Global Quality, Regulatory, Procurement and Process Development functions. Key duties involve the provision of material qualification oversight for new product launch and commercial manufacturing, using Process Development and Regulatory knowledge to enable effective management of business impacting change. A key element of the role will involve continuous improvement of the site business processes in partnership with global stakeholders.
This position will be part of the Manufacturing Science & Technology team and will be responsible for direct, indirect and single-use materials:
Serve as the point of contact for material qualification for the Dunboyne site and to support the network as required by the global product lifecycle management team.
Lead the material qualification process with respect to specification management, impact assessment, processing, creation of new Material Requests, associated documentation, review and approvals.
Project manage, and continuously improve, all qualification activities in accordance with the timelines outlined for commercial manufacturing and new product introduction.
Partner with global quality, regulatory, procurement and process development in the preparation of material qualification plans, using knowledge of manufacturing process changes and regulatory approvals to enable decision making.
Ensuring material selection and feasibility studies are complete prior to commencement of material qualification for new materials.
Collaborate with value stream functions to align technical requirements in Quality Agreements with site and global expectations, including the management of knowledge for new rare disease medicines.
Provide technical input to Process Development Reports, Questionnaires and Quality agreements for Material Supplier selection.
Ensure all material qualification related documents are received from suppliers and internal stakeholders, by providing oversight of the materials business process for accuracy and compliance.
Change management for existing materials that have been previously qualified, including technical /impact assessments.
Provide support for Supplier Non-Conformances (SNCs), associated internal communication of risks and tracking of remediation plans, in conjunction with quality assurance.
Provide expertise in health authority inspections related to material qualification and in the preparation of responses to health authority questions.
Provide technical information to the Supplier Quality Management Team for maintenance of the Supplier Qualification database.
Lead the collation of material qualification data to support preparation of metrics and reporting
Build safety as a value within every aspect of the value stream supporting operations.
Responsible for ensuring compliance with legal, EHS and all Shire policies and procedures applicable to the site.
Get personally involved in frontline EHS activities; inspections, GEMBA walks, meetings, forums, and investigations.
Recognize contributions and safety achievements. Take the time to find out about the effort people are putting in to improve safety, and meaningfully celebrate them.
Manage risk by asking the relevant questions to ensure that all risk is being identified, prioritized and controlled effectively.
Coach and mentor employees to be effective in their capability development of both self and others.
Engage pro-actively with teams through active 1:1s, skip levels, development planning, and regular site updates.
Celebrate with use of proactive recognition tools that inspire teams and individuals.
Create an environment where everyone speaks up for our culture of safety and looks out for one another.
Be an ambassador for the Shire leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
Role model the behaviours that creates a culture of respect and dignity in line with Shire Guide to ethical conduct.
Responsible for the goal setting in material management and providing feedback and coaching to each employee involved in the process.
Ensure project milestones for material qualifications are adhered to.
Monitor effectiveness the Material Review Board and associated governance processes for decision making.
Manage Budget to ensure material management related decisions support cost effective manufacturing.
Drive a high performance organizational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organization.
Participate in site and global material qualification and review board for Material Management and ensure decisions are data driven with clear requirements and timelines.
Attend leadership governance forums to present business performance metrics and to identify improvement opportunities.
Providing escalation of material qualification risks in a timely manner to leadership.
Track and manage associated regulatory requirements for material qualification for new and existing products.
Education and Experience Requirements
Strong experience in a material qualification role in the pharmaceutical or biotechnology industry desirable, combined with an understanding of process development and commercial manufacturing.
Bachelor’s Degree in a biological science, microbiology, chemistry, biochemistry or equivalent desirable
Competency in the use of Microsoft Office programs, including Word, PowerPoint and Excel is required. Database and SharePoint experience preferred.
Project management experience; Knowledge of /and experience with Project Management tools and processes desirable
Functional knowledge of Quality Systems required
Strong Knowledge in the areas of global cGMP regulations (US, EU, Japan, Canada, etc.), and quality management systems for pharmaceutical, device, biologics or biotechnology operations desired.
Knowledge of Regulatory authoring, review and submission processes for materials and changes is desired.
Experience in addressing health authority questions (US, EU, ROW) in relation to material qualification is desired.
Key Skills, Abilities, and Competencies
Excellent communication skills, both oral and written
Exceptional interpersonal and negotiating skills. Ability to develop and maintain professional relationships.
Critical thinking, analytical, and problem solving skills is desirable
Project management and analytical skills desirable.
Demonstrated sound judgment, confident, resourceful, self-reliant and self-motivated.
Prioritizes and manages time effectively to reliably meet timelines.
Basic business acumen desirable
Team player and collaboration oriented
Demonstrates effectiveness in project completion, training and problem-solving
Complexity and Problem Solving
Strong stakeholder management and problem-solving skills
Demonstrated ability in critical thinking and analytical skills to support decision making
Internal and External Contacts
Interactions with Shire external business partners and suppliers.
Interacts with Shire internal stakeholders in project teams, capital project, site managers and leadership.
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.