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.

This is what you will do:

The QC Senior Manager of Microbiology, will lead and manage all aspects related to facility and laboratory support at the Dublin site. The role is responsible for managing the testing of in-process, drug substance and drug product release and stability testing in support of the College Park manufacturing facility as well as the Global QC Centre of Excellence. In addition, the role will work closely with the Dublin facility Microbiology Contamination Control Lead and the Microbiology QC management team in the Alexion Athlone facility. The role will also support the strategic efforts ongoing regarding capacity management and lean labs.

You will be responsible for:

• Management of the QC team, to allow the laboratory to perform as an in-process, release and stability testing environment in addition to provision of microbiological facility support. This role will also assume accountability for non-direct testing activities
• Manage all network support activities and ensure they are delivered on time and within budget
• Managing schedules and targets to meet regulatory and business requirements.
• Managing the validation/qualification of Microbiology test methods and test systems to support in process and commercial release testing.
• Manage QC inspection readiness for all inspections and represent QC in audits and inspections
• Support the sterility assurance program for the facility to maintain a robust aseptic processing and monitoring program.
• Provide SME support to the Manufacturing and Projects teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness.
• Represent QC at product and technical team meetings and lead/drive all associated support activities
• Support the training strategy for QC, managing the development, operation and evaluation of training/re-training programs
• Accountable to implement efficient processes, tracking and reporting on improvements including cost, productivity and waste/rework. Responsible to implement and sustain Lean Lab initiatives, including performance management, right first time, standard work, visual management and tiered metrics/KPIs.
• Represent and support the laboratories for all Investigations. Manage the timelines and compliance to Alexion Ireland procedures on investigations ensuring compliant, robust approach to LIR (lab investigation reports), Deviations and appropriate CAPA.
• Lead QC product report out to management
• Responsible for QC support of the APQR process and Process Monitoring support
• Support management in continual enhancement of the QC strategic plan
• Personnel development, SMART objective setting and coaching completing regular One: Ones with all direct reports
• Lead and maintain a high performing team, including QC analysts, specialists, supervisors and managers with the QC Analytical Team. Accountable for the team operating model, org structure, people and talent strategy, succession planning, reward & recognition.

You will need to have:

• B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
• Minimum 10 years’ microbiological experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment
• A high degree of technical competency in Microbiology methods, sterility assurance and aseptic filling.
• Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
• Excellent communication and interpersonal skills
• Experience of involvement in technical issue resolution, in a multidisciplinary environment

We would prefer for you to have:

• 5+ years of supervisory/ management leadership experience
• Experience of Trackwise and documentation systems would be an advantage.
• Proven record in demonstrating agility
• Project management skills.
• High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint.

#LI-GO1

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.