The Supervisor will oversee the operations and staff on the manufacturing floor. They will assist with equipment start-up and participate in ANDA batch production and commercial batch manufacturing.
Responsibilities
Oversee all activities on the manufacturing floor, ensuring safety, quality, and 100% GMP compliance. Plan and schedule manufacturing and packaging to meet deadlines and prevent back orders.
Work closely with the quality group to ensure ongoing compliance; participate in investigations; support the R&D process and execution of new products; provide information during 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, leading and demonstrating the actual methods and procedures using state-of-the-art equipment and recipe-driven controlled systems.
Communicate effectively with staff daily to ensure everyone is up to speed with pertinent departmental and company events.
Qualifications
Required: Associate Degree Related field + 5 yrs exp leading and training staff
Preferred: Bachelor's Degree (BA/BS) Related field
3 years or more in Transdermal drug delivery or manufacturing GMP environment
3 years or more in Leading and training staff
Skills
Strong analytical and quantitative skills with good common sense. - Intermediate
Excellent oral and written communication skills. - Intermediate
Able to multi-task and advance multiple programs simultaneously. Takes thoughtful and timely action when confronted with a problem. - Intermediate
Ability to adapt to changes in assignments, flexibility, and willingness to work extended hours. - Intermediate
Strong team player. - Intermediate
Specialized Knowledge: Transdermal, Converting, Packaging Experience within a GMP Manufacturing Environment
Education
Bachelor's Degree (BA/BS) Related field - Preferred
Associate Degree Related field + 5 yrs exp leading and training staff - Required