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Technical Shift Lead (Biologics Manufacturing)

Job description

Technical Shift Lead (Biologics Manufacturing) – Shift – Co. Mayo
Job Description
My client, a Biologics manufacturing multinational, is recruiting for technical experts to join their Biopharma operations team as a new Technical Shift Leader. In the role, you will have the opportunity to lead an established team developing and guiding its members technically and professionally. 
Delivering high levels of customer service, in this role, you will ensure the quality of the product, comply with all regulatory requirements, achieve desired financial performance, including cost reductions, and build a high-performance culture for the team.
If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:

Key activities:

  • Act as your team's key point of contact and technical expert.

  • Lead and support your team to deliver compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation and processing activities in the biologics fill-finish facility to meet clearly stated operating objectives

  • Coach & mentor your manufacturing team to maximize its effectiveness through clear and effective communication

  • Promote and develop a culture of contamination control and compliance with aseptic best practices

  • Communicate departmental goals to provide cost-effective quality compliant products in a safe, effective manner

  • Collaborate with program management, supply chain, technical operations, quality, and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing

  • Resolve operations/project issues with team members, project customers, and others as appropriate.

  • Drive operations excellence and key operations targets, including OEE where applicable

  • Provide direct interface as a subject matter expert with the QA department to interact with HPRA, FDA and applicable health authorities and internal audits.

Education and preferred experience:

  • Minimum of 5 years’ experience in batch processing, automation, commissioning, and/or validation in an FDA/HHPRA-regulated industry.

  • Bachelor’s degree in chemistry, pharmacy, engineering or a related scientific field is required; an advanced degree is preferred.

  • Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.

  • Comprehensive understanding of contamination control principles and regulatory expectations for aseptic processing.

  • Technical background in pharmaceutical, biologics, or similar industries.

  • A minimum of 1 year of direct supervisory experience in a team environment is preferred

  • Possess strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises the appropriate actions