BrightOwl Loader Loading

Operations Supervisor - Biologics Athlone Ireland,  

Alexion (company)

Posted on : 07 May 2017

Project Description

  • Our company  is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. 
  • Our company is the global leader in complement inhibition and has developed and markets a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. 
  • Our company is evaluating other potential indications for its marketed drug and is developing additional highly innovative biotechnology product candidates across multiple therapeutic areas.


Position Summary
  • The Biologics Supervisor is accountable for all Operational functions at the company  Facility from start up through to commercial readiness. 
  • This includes ensuring all activities for commercial and/or clinical products are completed in accordance with cGMP, Corporate and Regulatory requirements.
  •  The incumbent must be technically strong and must ensure effective interaction with other departments and locations regarding Operational activities and GMP Document review.


Principal Responsibilities
  • Complete operational activities in accordance with applicable procedures, corporate policies, and cGMP.
  • Work with other departments to understand future needs and to adhere to the production schedule
  • Trend issues and performance for business review meetings.
  • Support Operations teams - identify problems, recommend process improvements, and work with the team on resolutions.
  • Work closely with internal stakeholders such as Facilities Management, Quality Departments, and Corporate Finance.
  • Provide input and oversight for all start-up project activities through to commercial readiness and ongoing product disposition.
  • Provide SME support for the area during regulatory inspections.
  • Responsible for change controls, deviations and CAPA s related to Operations
  • Develop and implement metrics.
  • Review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports to meet the needs of Clinical and Commercial Operations groups.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
  • Actively contributes to continuous improvement activities.
  • Capable of performing, monitoring, and resolving all SAP transactions supporting department
  • Ensures compliance with designated hazardous materials regulations
  • Provide performance reviews to direct reports; counsel and discipline under-performing employees
  • Deliver on project timelines.


  • 3 - 7 years of people management experience in a biopharmaceutical or pharmaceutical environment, preferred.
  • Excellent understanding of cGMP relevant to Purification and Biologics an advantage.
  • Excellent interpersonal, persuasion and communication skills.
  • Customer service oriented, self -directed, responsible, and able to work on problems of moderate scope involving various cross-functional groups.
  • Flexible and comfortable with ambiguity.
  • Direct experience of GMP within a pharma/biopharma company and will include exposure to FDA, HPRA or other authorities of similar standing.


  • Third level qualification e.g. B.Sc in Science, Engineering or other relevant qualification. 


Athlone IE

Find a Job Find Candidates

Similar Jobs

More jobs from alexion

Other jobs in Ireland

Other jobs in Athlone

Other similar job in Athlone

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like