Role Summary
Supervisor, Transdermal. The role involves overseeing operations and staff on the manufacturing floor, assisting with equipment start-up, and participating in ANDA batch production and commercial batch manufacturing.
Responsibilities
- Oversee all activities on 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 ongoing compliance; participate in investigations; support R&D processes and provide information during new product development.
- Act as a Working Supervisor to manufacture various R&D batches, train operators in processing and equipment capabilities.
- 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; demonstrate methods and procedures using state-of-the-art equipment and recipe-driven systems.
- Communicate effectively with staff daily to keep everyone informed of departmental and company events.
Additional Responsibilities
- R&D and commercial scale-up activities.
- Continuous improvement initiatives.
Qualifications
Education
- Bachelors Degree (BA/BS) in a related field - Preferred
- Associate Degree in related field + 5 years' experience leading and training staff - Required
Experience
- 3+ years in transdermal drug delivery or GMP manufacturing environment
- 3+ years in leading and training staff
Skills
- Strong analytical and quantitative skills with good common sense
- Excellent oral and written communication skills
- Ability to multi-task and manage multiple programs concurrently; takes thoughtful and timely action when problems arise
- Adaptability to changes, flexibility, and willingness to work extended hours
- Strong team player
Specialized Knowledge
- Transdermal, converting, and packaging experience within a GMP manufacturing environment