Within this role you will be responsible for supervising the implementation of commercial manufacturing production schedules and supervising the manufacturing team in relation to process execution for Upstream / Midstream and / or Downstream processes.
This is a shift position.
In this role daily tasks will include, but are not limited to, the following :
Supervising commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule
Supervising a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment
Ensuring that the highest safety and housekeeping standards are maintained
Supervising all aspects of respective areas of operations
Reviewing and edits batch records in accordance 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; troubleshooting 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
Interfacing 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 might be for you if :
You possess logical troubleshooting and problem-solving skills
You have excellent analytical, written and oral communication skills
You demonstrate an ability to lead a successful team
To be considered you should have a 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.
IRELIM #LI-Onsite #JOBSIEST
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