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 support the technical transfer process, batch record generation, investigation, and process improvement for cGMP parenteral manufacturing.
Essential Job Function/Duties
• Technically support cGMP manufacturing activities for parenteral products, both ongoing and transferring in new products, including dispensing, formulation, filling, lyophilization, capping, terminal sterilization, and inspection
• Investigate and recommend corrective/preventive actions for ongoing manufacturing processes
• Plan and participate in manufacturing site audits (cGMP and/or technical) as required
• Generate batch records in coordination with equipment recipe authors
• Lead/facilitate process improvement activities
Minimum Work Experience/Education Requirements
• Bachelors Degree in Science or Engineering and 3+ years of experience in parenteral manufacturing or related field
Masters Degree in Science or Engineering and 1+ year parenteral manufacturing experience
6+ years of technical transfer experience
• Knowledge of biopharmaceutical regulatory and cGMP requirements is required
• Knowledge of computer systems, electronic records, data trending, and evaluation
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.
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...