Role Summary
The Supervisor will oversee the operations and staff on the manufacturing floor, assist with equipment start-up, and participate in ANDA batch production and commercial batch manufacturing. This role follows a 12-hour rotating schedule, from 6:00 AM to 6:30 PM.
Responsibilities
- Oversee all activities on the manufacturing floor to ensure safety, quality, and productivity while maintaining GMP compliance. Plan and schedule manufacturing and packaging to meet deadlines and prevent back orders.
- Collaborate with the quality group to ensure ongoing compliance, participate in investigations, and support R&D processes and new product information during development and production.
- Act as a Working Supervisor to manufacture R&D batches (large and small scale), train operators on processing and equipment capabilities.
- Participate in equipment setup, IQ/OQ/PQ, and commercial batch activities. Set up, run, and clean equipment in a GMP environment, performing mixing, coating, converting, pouching, and cartoning operations; lead by example in executing methods and procedures using advanced equipment and recipe-driven systems.
- Communicate effectively with staff daily to keep everyone informed of departmental and company events.
Qualifications
- Education: Preferred Bachelorβs Degree in a related field; Required Associate Degree in a related field with 5+ years of experience leading and training staff.
- Experience: 3+ years in transdermal drug delivery or a GMP manufacturing environment; 3+ years of experience in leading and training staff.
Skills
- Strong analytical and quantitative skills with good judgment. - Intermediate
- Excellent oral and written communication skills. - Intermediate
- Ability to multi-task and manage multiple programs simultaneously; take timely action when problems arise. - Intermediate
- Adaptability to changing assignments, flexibility, and willingness to work extended hours. - Intermediate
- Strong team player. - Intermediate
Education
- BA/BS in a related field (Preferred)
- Associate Degree in a related field with 5+ years of leadership/training experience (Required)
Additional Requirements
- OSHA-compliant Respirator Fit Test must be successfully completed.