Job Summary:

Assists Supervisor and provides daily leadership to employees in the Manufacturing department to ensure safety and quality, maximizing productivity and efficiency while fostering a positive work environment. Plans and communicates daily production needs within the team. Coordinates, trains, mentors, and leads the blending, coating/drying/laminating (CDL) and Finishing operators for Aveva’s transdermal and transmucosal products.  Leads manufacturing teams on all assigned job duties, communicating overtime needs, training of new hires, and helping R&D with new processes as Subject Matter Expert. Keeps the supervisor informed of all issues that occur on the shift.

Job Responsibilities:

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal, and local laws.
• Leads, Trains, mentors, and leads blending, coating/drying/laminating (CDL) and Finishing operations staff in blending operations and assists in the training of Blender Operator I staff throughout all other manufacturing operations. Restocks supply rooms and cleans blending and manufacturing facilities.
• Coordinates all manufacturing crews in their daily activities.
• Assemble and disassemble all blending and manufacturing equipment.
• Ensures Operators monitor and document the critical process parameters during the manufacturing process. 
• Investigates process problems, notifies Supervisors, and takes appropriate corrective actions.
• Performs batch processing steps in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
• Verifies the correctness of all raw materials against the appropriate issuance documents to ensure that the correct materials are used during the manufacturing process.
• Knowledge of blending room control panel functionality including but not limited to temperature controllers and chart laminate.
• Work with active drug products, adhesives, solvents and various other chemicals to perform all steps in the manufacturing process.
• Wear appropriate personal protective equipment for blending or manufacturing tasks being performed.
• Weigh and document the weights of raw materials, components, and product intermediaries.
• Provide input and evaluate revisions and the creation of blending batch records.
• Maintain all blending and kettle storage rooms in a clean and organized manner.
• Aid R&D with trial, scale-up and clinical blend batches.
• Document manufacturing steps performed in the coating/drying/laminating (CDL) and Finishing batch records and perform batch record accountability records.
• Document operational parameters for manufacturing equipment and provide input in the creation of all manufacturing batch records.
• Help maintain the blending, coating/drying/laminating (CDL) and Finishing parts inventory and perform on-line coat weight sampling operations.
• Prepare finished or slit laminate rolls.
• Maintain and clean manufacturing and production areas and equipment.
• Document work performed in appropriate logbooks.
• Perform on-line coat weight and sampling operations.
• Perform other job tasks within production and other departments as needed.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our corporate values: Innovate, Evolve and Excel.
• All other relevant duties as assigned.
• Ensures housekeeping standards are followed and area is maintained during shift.
• Ensures area housekeeping / 5s initiatives are sustained, and all other relevant duties as assigned.

Job Requirements

• Education

• High school diploma or general education degree (GED).

• Experience
  • 10 years' experience in a fast-paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required. Transdermal Manufacturing/ Packaging experience preferred.
  • Demonstrate career progression within Aveva with a minimum of 3 years' experience as a Back-up Section Leader, or equivalent related experience.

• Education
• High school diploma or general education degree (GED).

• Experience
  • 10 years experience in a fast-paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required. Transdermal Manufacturing/ Packaging experience preferred.
  • Demonstrate career progression within Aveva with a minimum of 3 years experience as a Back-up Section Leader, or equivalent related experience.