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Some opportunities happen only once in a lifetime - like a job where you have the chance to 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.


The Senior Manager BDS is responsible for supporting commercial production within the Bulk Drug Substance facility at Alexion’s College Park plant in Dublin. Reporting to the director of BDS Operations the candidate will provide technical support to the BDS operations team. They will be providing support around including investigations, changes, improvement projects, technical training and documentation. They will provide a key interface between the shift operations teams and day-based function support.


You will be responsible for:

  • Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • Provide expert technical and documentation support to investigations, change controls, training and improvement projects ensure the manufacture of bulk 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.
  • Take a lead role in ensuring that Operations procedures, electronic batch records and other documentation are suitable for the right first time execution of BDS in college park
  • Take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
  • Liaise with the teams responsible for planning and implementing new product introductions , ensuring that new work instructions, EBRs, change controls and product changeover protocols are in place in a standardized end efficient manner.
  • Member of the BDS Leadership Team. Contribute to the site operating performance and utilization of resources, planned launches of new products, and need for continuous improvement of product flows to optimize the speed and efficiency of the supply chain while increasing robustness and decreasing costs.
  • Develop and maintain strong and effective relationships with partners at College Park including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance. Contribute to best practice sharing with Manufacturing colleagues at other Alexion facilities.
  • Take an active role in operational excellence and using Lean and six-sigma tools to achieve measurable improvements in manufacturing
  • Advise and assist with the preparation and execution of any governing body regulatory inspection

You will need to have:

  • A minimum of 8 years’ experience in Manufacturing Operations in a biopharmaceutical company
  • Demonstrated leadership of technical and / or operational teams within a biopharmaceutical operations organization.
  • Excellent people management, communications and decision-making skills
  • Experience of biological manufacturing processes
  • Experience of capacity expansion and new product introduction project work
  • Experience of leading operational excellence and using Lean and six-sigma tools to achieve measurable improvements in a manufacturing setting is strongly desirable.
  • Undergraduate degree in science or engineering or equivalent is required

We would prefer for you to have:

  • Post-graduate qualification in a relevant biotech/engineering field

#LI-MH2


Alexion is 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. Further information about Alexion can be found at: www.alexion.com.


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 lack thereof, sex, sexual orientation, 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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. 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, click here.

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Deadline: 30-03-2024

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