Role Summary
Supervisor, Transdermal - 12 Hours (3rd Shift) responsible for overseeing manufacturing floor operations, equipment start-up support, and participation in ANDA and commercial batch production. Role follows a 12-hour rotating schedule from 6:00 PM to 6:30 AM.
Responsibilities
- Oversee all activities throughout the manufacturing floor, ensuring safety, quality, and productivity with 100% GMP compliance. Plan and schedule manufacturing and packaging to meet deadlines and prevent back orders.
- Work with the quality group to ensure continuous compliance; participate in investigations; support R&D processes and contribute information during new product processes.
- Act as a "Working Supervisor" to manufacture various R&D large/small scale batches; train operators in processing and equipment capabilities for all production.
- Participate in equipment set-up, IQ/OQ/PQ, and commercial batch activities. Set up, run, and clean equipment in a GMP environment; conduct mixing, coating, converting, pouching, and cartoning operations; demonstrate methods and procedures using state-of-the-art equipment and systems.
- Communicate effectively with staff daily to keep everyone informed of pertinent departmental and/or company events.
Qualifications
- Education:
- Bachelors Degree (BA/BS) Related field - Preferred
- Associate Degree Related field + 5 yrs exp leading and training staff - Required
- Experience:
- 3+ years in Transdermal drug delivery or GMP manufacturing environment
- 3+ years leading and training staff
- Skills:
- Strong analytical and quantitative skills with good common sense (Intermediate)
- Excellent oral and written communication skills (Intermediate)
- Ability to multi-task and manage multiple programs; proactive problem solving (Intermediate)
- Adaptability to changing assignments; willing to work extended hours (Intermediate)
- Strong team player (Intermediate)
- Specialized Knowledge:
- Transdermal, Converting, Packaging experience within a GMP manufacturing environment
Additional Requirements
- OSHA-compliant Respirator Fit Test required.