- Reference: GY45539
- Job Type: Permanent
- Location: Limerick
- Category: Production
This is an excellent opportunity to join a select team that is already leading the way in the Pharmaceutical/Biotech industry.
- Supervises manufacturing of recombinant proteins according to approved protocols, regulation, and schedule.
- Supervises a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
- Ensures that the highest safety and housekeeping standards are maintained.
- Supervises all aspects of respective areas of operations.
- Reviews and edits batch records in accordance with cGMP standards.
- Ensures availability of production batch records for upcoming lots
- Schedules shift duties and batch tasks based on master production schedule.
- Ensures equipment readiness and coordinates regular equipment maintenance and calibrations; troubleshoots equipment
- Performs cGMP audits of production area.
- Performs people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.Schedules individual and ongoing training.
- Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
- Ensures that safety standards are maintained at all times.
Skills, Experience & Qualifications:
- Requires BS/BA in Life Sciences or related field with 5+ years of relevant cGMP manufacturing experience and some previous supervisory/leadership experience. Will substitute relevant experience in lieu of educational requirement.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org