Biotech Production Operations Manager

3 days ago

Limerick, Limerick, Ireland beBeeBiotechnology Full time €80,000 - €100,000
Job Title

We are seeking a Biotech Production Supervisor to oversee the implementation of commercial manufacturing production schedules.

  • Supervising commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule.
  • Leading all aspects of a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
  • Ensuring the maintenance of the highest safety and housekeeping standards.
  • Reviewing and editing batch records in line with cGMP standards.
  • Ensuring availability of production batch records for upcoming lots.
  • Scheduling duties and batch tasks based on master production schedule.
  • Ensuring equipment readiness and coordinating regular equipment maintenance and calibrations; troubleshoots equipment.
  • Performing cGMP audits of production area.
  • Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.
  • Scheduling individual and ongoing training.
  • Collaborating with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
  • Ensuring that safety standards are maintained at all times.

This role requires:

  • Previous supervisory and or leadership experience.
  • Logical troubleshooting and problem-solving skills.
  • Excellent analytical, written and oral communication skills.
  • The ability to work within a successful team.

Requirements include a BS/BA in Life Sciences or related field with 5+ years experience within manufacturing, and experience leading manufacturing shift teams is required.

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