Title: Manufacturing Specialist
Salary: Highly Competitive
The Manufacturing Specialist is responsible forโฆ
- Supervising manufacturing department (ex. Equipment preparation, formulation, filtration, aseptic, non-aseptic compounding, preparation, packaging and filling activities)
- Ensure safety of manufacturing area
- Coordinate and supervise manufacturing personnel in the cGMP operations
- Manage and develop a team focused on very complex operations producing pharmaceutical and medical device products for clinical and commercial operations
- Partner with the planning department to ensure effective prioritization and schedule adherence
- Ensure efficient operation of process floor activities
- Guide/train employees to ensure QSR and ISO requirements have been properly implemented and met.
- Become a hands-on team builder to motivate, coach, support, retain, and inspire effective teams
- Collaborate with the operations, material management, engineering, MTS, finance and R&D teams to optimize processes
- Responsible for maintaining the highest level of regulatory compliance
- Recruit and supervisor staff to execute department functions
Proactively identifies, assesses, and mitigates operational and organizational risks
- Establish key performance indicators
The Manufacturing Specialist should have the following qualifications:
- ***Must have aseptic fill/finish process experience
- Lyophilization experience is a must
- Bachelor's degree in science related field
- Experience with GMP, ISO and/or an FDA regulated environment is required
- 7-10 years of experience in a cGMPs/ISO environment
- Minimum 5 years (prefer 7) of experience leading direct reports or a team
- PC skills, MS Office and Microsoft project applications required
- Six Sigma experience is a plus
Benefits/Perks
This firm offers a highly competitive benefits package.
If you are interested in the Manufacturing Supervisor role, then apply today!