Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world's largest privately held medical manufacturing company.
To provide leadership and direction in the planning and operation of the Formulation, Filling, and Finishing (FFF) functions at Cook Pharmica.
Essential Job Functions/Duties
• Direct and manage the filling operations of the Class 100 areas, vial processing lyophilization and product sterilization operations
• Oversee the completion and review of all filling vial washing lyophilization and product sterilization batch record documentation
• Direct and manage staff of the production schedule in terms of staffing, work schedules, planning related work activities, and equipment maintenance
• E nsure required personnel are available to complete line set-up, line changeovers, line cleaning / sanitization, and the operation of all machinery in the Class 100 / vial washing areas in a timely and accurate manner
• Assist with writing new SOPs to accurately cover all significant activities within the Department
Support trained staff to be available and scheduled to ensure all filling operations will function at optimum levels
• Assure technical assistance for Validation and Engineering protocols is provided as required
Minimum Work Experience/Educational Requirements
• Bachelors Degree in Science or Engineering or related fields or equivalent experience is required
• Minimum of 5 years supervisory experience is required
• Minimum of 10 years pharmaceutical experience with direct experience in the area of aseptic filling and small volume parenteral manufacturing Sterile/aseptic pharmaceutical manufacturing including product aseptic filling
• Required to sign a confidentiality and a non-compete agreement
Physical Requirements/Work Environment
• Must be able to lift/push/pull up to 50 pounds on a consistent basis
• Potential limited exposure to hazardous chemicals
• Must be able to work in an environment that can affect an electronic implant device (i.e. pacemaker, auto injector, etc.)
• Work time split between computer desk and production floor/clean rooms
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
Sign the non-competition and confidentiality agreements. Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, and Cook Pharmica Quality Manual
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Cook Medical - 10 months ago