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Operations Supervisor - Biologics - Ireland  

Company managed [?] Still accepting applications

Posted on : 07 May 2017

Project Description

 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.

 

Qualifications
  • 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.

 

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