- 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.
- 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.
- 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.