Job Description:
As a Supervisor Biotech Production, you will be responsible for overseeing the implementation of commercial manufacturing production schedules and guiding the manufacturing team in executing processes for manufacturing operations.
Key Responsibilities:
* Supervising commercial scale manufacturing of recombinant proteins according to approved protocols, regulations, and schedules.
* Leading a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
* Maintaining the highest safety and housekeeping standards.
* Overseeing all aspects of respective areas of operations.
* Reviewing and editing 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 schedules.
* Coordinating regular equipment maintenance and calibrations; troubleshooting equipment.
* Performing cGMP audits of production areas.
* Handling 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.
Requirements:
* Demonstrated previous supervisory and/or leadership experience is required.
* Possess logical troubleshooting and problem-solving skills.
* Excellent analytical, written, and oral communication skills.
* Able to work within a successful team.
Qualifications:
A Bachelor's degree in Life Sciences or a related field, with 5+ years of relevant cGMP manufacturing experience. Relevant experience may substitute for educational requirements.