Some opportunities happen only once in a lifetime – like a job where you have the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
This role is responsible for all cGMP drug substance manufacturing activities at the Alexion Dublin Manufacturing Facility in Ireland. The position will lead the site’s Manufacturing Operations team; foster effective cross-functional collaboration with EHS, Quality Assurance, Quality Control, Engineering/Maintenance, Technical Services, and Supply Chain groups; partner with NPI project teams and Technical Operations to introduce new products and process improvements.
This position will ensure that the Drug Substance facility is operated to the highest standards of safety and cGMP regulatory standards. The person in this position will be responsible for the operational introduction of new products to the facility, ensuring all regulatory approvals are achieved to the required schedule.
This role is also responsible for delivering key strategic initiatives for the site including multi-product production, future capacity in line with the long-term plan and process improvements that lead to improved performance in sustainability and cost.
The person in this role is a core member of the Site Leadership Team and responsible for ensuring that the site delivers on its production plan and KPI’s.
You will be responsible for:
- Recruiting, retaining and developing a first class manufacturing team to support manufacturing operations. Build and sustain employee engagement by creating a culture that balances safety, compliance, and continuous improvement. Foster an environment in which individuals and teams can excel and grow
- Ensure the manufacture of drug substance is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements
- Responsible for ensuring all new product introductions to the Dublin site are delivered to schedule
- Ensure appropriate training of all manufacturing personnel is maintained and up to date
- Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in preparing, standing, and responding to regulatory inspections
- Maximize the performance of operations by instituting continuous improvements tools and programs
- Communicate operational status regularly to the Site Leadership Team and to Alexion Operations Leadership at the appropriate level of detail
- Support implementation of capital projects within budgets and timelines
- As the business owner for MES, ensure that MES and other systems are implemented and optimized within the facility
- Lead and facilitate cross-functional projects to achieve corporate objectives
- Keep stakeholders informed of key decisions, changes, risks, and progress to major project and operational milestones
- Leverage operational excellence and metrics to control and improve operational performance
- Actively manage plant capacity and throughput to an agreed road map
You will need to have:
- A minimum of 15 years of pharmaceutical experience overseeing Drug Substance operations, quality and/or technical services, with multiple areas of experience preferred
- Leadership of both operations and support functions within a biopharmaceutical company
- Excellent people management, communications, and decision-making skills
- Experience with biological drug substance manufacturing
- Experience with capacity expansion and new product introduction project work is essential
- Experience with 24/7 shift operations is desirable
- Demonstrated ability to organize and lead manufacturing operations
- Demonstrated ability to manage both tactically and strategically, to prepare contingency plans and ensure execution of plans through effective organizational delegation
- Experience managing budgets and overseeing financial controls
We would prefer for you to have:
- Degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field
- Advanced degree (MS, PhD, MBA) is an advantage
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.