Job Title
Senior Manufacturing Team Lead
Location
Ringaskiddy, Cork, Ireland
Job Summary
Reporting to the Cell Culture, Purification or Manufacturing Science and Technology (MSAT) Manager, this position is responsible for coordination, organization, and scheduling of shift team activities within the Operations department. It includes managing resources and leading operations shifts to ensure shift targets are met.
Responsibilities
Work assigned day or shift patterns to meet business needs and operations schedule.
Coordinate operations team to meet production schedule in a safe, compliant, and cost-effective manner.
Complete pulse walkdowns to ensure compliance with regulatory and cGMP requirements.
Troubleshoot process issues and collaborate with relevant support to resolve them timely.
Review and approve completed batch records.
Support project and commissioning/qualification activities as required.
Cell Culture Activities
Employ strict aseptic technique for all cell culture activities.
Continuously monitor cell culture process.
Set up and assemble the bioreactor single‑use bioreactors.
Manage harvest release and downstream processing, accurate buffer requirements.
Maintain focus on reliability.
Purification Activities
Process chromatography using Unicorn/Delta V control system.
Perform filtration, virus filtration, and ultrafiltration of purified product.
Execute final filtration, filling, and finishing of purified product.
Required Qualifications
Third level or equivalent qualification.
Demonstrated leadership capabilities in previous roles.
Understanding of cGMP and familiarity with other regulatory requirements.
Desirable
Scientific or technical qualification.
Supervisory experience.
Operations experience within a GMP regulated environment.
Operations experience within a life sciences or biopharmaceutical environment.
Additional Information
Execution of operations activities as necessary to meet operational needs to the highest standards.
Prioritize and schedule activities to support business needs and Master Production Schedule.
Oversee all activities in compliance with corporate and cGMP/EHS regulatory requirements.
Facilitate root cause problem solving sessions.
Maintain and calibrate operations equipment, support commissioning \& qualification activities.
Develop systems to monitor quality and efficiency, implementing continuous improvement strategies.
Provide coaching and feedback to the team.
Participate in regulatory audits and ensure audit readiness.
Support commissioning and qualification activities.
Deputize for operations manager as necessary.
Significant Environmental, Health & Safety Considerations
Take reasonable care to protect own and colleagues' safety.
Comply with EHS rules and procedures at all times.
Understand potential EHS impact of activities.
Attend and participate in EHS training as required.
Use PPE and safety equipment as required.
Report all incidents, accidents, and near‑miss events.
Benefits and Compensation
The anticipated base pay range for this position is €63,000 to €101,315. In addition to base pay, the role offers an annual bonus with a set target, vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, and programs for financial, physical and mental health. Employees may also participate in service anniversary and recognition awards, along with various insurance plans and other benefits as applicable.
EEO Statement
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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