Job Summary
This role involves supervising the implementation of commercial manufacturing production schedules. You will be responsible for overseeing the manufacturing team in relation to process execution for Manufacturing processes.
Key Responsibilities
* Supervise commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule.
* Supervise a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
* Maintain the highest safety and housekeeping standards.
* Review and edit batch records in accordance with cGMP standards.
* Schedule duties and batch tasks based on the master production schedule.
* Ensure equipment readiness and coordinate regular equipment maintenance and calibrations.
* Perform cGMP audits of production areas.
* Carry out people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.
* Schedule individual and ongoing training.
* Interface with other departments such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control.
Requirements
* Demonstrate previous supervisory and or leadership experience.
* Possess logical troubleshooting and problem-solving skills.
* Have excellent analytical, written, and oral communication skills.
* Demonstrate an ability to work within a successful team.
Qualifications
* Bachelor's degree in Life Sciences or a related field.
* At least 5 years of relevant cGMP manufacturing experience.