Biologics Manufacturing Team Lead

Team Horizon is seeking a Biologics Manufacturing Team Lead to join our client’s site in Sligo. The Biologics Manufacturing Team Lead will lead and facilitate the biologics operations of the operations team in line with all safety, regulatory and organizational requirements.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build an inclusive culture of high performance for the team.


• Supervision and execution of filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives.


• Create an environment where safety is the number one priority in every activity that you do, driving safety improvements and conducting safety Gembas routinely.


• Be present on the floor promoting a culture of zero safety incidents in compliance with all EHS requirements.


• Proactively review daily work activities to highlight any high risk activities.


• Drive safety improvements and initiatives across the operation.


• Adheres to and supports all EHS & E standards, procedures and policies.


• Promotion of a culture of contamination control and compliance with aseptic best practice.


• Responsible for daily effective deployment of team members and ensuring tasks are appropriately delegated to meet the production schedule.


• Daily reporting on the status of all operations and support activities.


• Team leadership, motivation, and direction to maximise the effectiveness of the manufacturing team.


• Resolves operations/project issues by working with team members, project customers, and other stakeholders as appropriate.


• Develop direct reports by securing appropriate training, assigning progressively challenging tasks and managing mid-year and annual reviews.


• Responsible for driving operations excellences and Key operations targets including OEE where applicable.


• Responsible for manufacturing compliance with all safety, environmental and quality related SOPs.


• Work closely with the other Technical Shift Leaders to ensure interdepartmental activities are planned and executed safely.


• Any additional duties as assigned.

What you need to apply:

• Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline


• A minimum of 5 years’ experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry.


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


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


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


• Has a technical background in pharmaceutical, biologics, or similar industries.


• Experience of start-ups and/or new product introductions to biopharmaceutical/pharmaceutical facilities (Biologics Preferred).


• Must be able to lead & project manage these activities.


• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.