Job Summary
This role is responsible for supervising the implementation of commercial manufacturing production schedules and overseeing the manufacturing team in relation to process execution for manufacturing processes. This is a shift position that requires individuals to work various hours, including nights and weekends.
About the Role
1. Supervise commercial scale manufacturing of recombinant proteins according to approved protocols, regulations, and schedules.
2. Oversee a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
3. Evaluate and maintain high safety and housekeeping standards within the production area.
4. SUPERVISE ALL ASPECTS OF RESPECTIVE AREAS OF OPERATIONS.
5. Review and edit batch records in accordance with cGMP standards.
6. Ensure availability of production batch records for upcoming lots.
7. Schedule duties and batch tasks based on master production schedule.
8. Maintain equipment readiness and coordinate regular equipment maintenance and calibrations, as well as troubleshoot any issues.
9. Perform cGMP audits of production areas.
10. Manage personnel responsibilities, including time sheet submissions, scheduling vacations, employee development, disciplinary actions, hiring, terminations, and performance evaluations.
11. Schedule individual and ongoing training.
12. Interface with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control.
13. Ensure that safety standards are maintained at all times.
About You
1. You will be a successful candidate if you have previous supervisory or leadership experience.
2. You possess strong logical troubleshooting and problem-solving skills.
3. You demonstrate excellent analytical, written, and oral communication skills.
4. You are able to work effectively within a successful team.
Requirements
To be considered for this opportunity, you should have a BS/BA in Life Sciences or a related field with 5+ years of relevant cGMP manufacturing experience. Relevant experience may substitute educational requirement.