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 lead and facilitate the technical transfer process, implement new technologies and improve processes for CGMP parenteral manufacturing.
Essential Job Function/Duties
• Participate in client visits, on-site and off-site, to represent Drug Product capabilities and expertise
• Develop/maintain the system and process of Drug Product technical transfer by project phase and type
• Continuously improve the technical transfer process and experience for internal and external customers
• Assess and evaluate new projects; provide technical support for the development of new project proposals
• Provide technical leadership on complex, ‘one-source’ projects, and strategic partnerships – technical transfer
• Provide leadership for both strategic and tactical initiatives for Drug Product materials and components
• Identify, evaluate, and implement new tools and technologies within Drug Product operations to reduce cost, risk, product loss, etc.
Minimum Work Experience/Education Requirements
• A minimum of 8-10 years in parenteral manufacturing or a commensurate level of experience with related processes
• BA/BS/MS in chemistry, engineering, pharmaceutics, or related discipline or equivalent industry experience
• Knowledge of biopharmaceutical regulatory and cGMP requirements
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 - 19 months ago
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Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...