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 Principal Scientist in conducting laboratory and pilot plant experiments to develop and improve formulation processes and operations, adhering to customer, regulatory, safety and environmental requirements and guidelines. To operate in a learning environment and demostrate flexibility as needed to support process development work.
Essential Job Functions/Duties
• Develop prototype liquid and solid protein formulations
• Assist in bioanalytical development as needed
• Collect and analyze data, maintaining laboratory notebooks
• Evaluate excipients and vehicles and performs drug-excipient compatibility studies to prepare formulations in-vitro and in-vivo studies
• Evaluate physic-chemical characteristics of proteins (pH stability profile, oligomerization/aggregation, particle size distribution, solid and liquid stability studies)
• Assist in the preparation of technical documents, including specifications, protocols, reports, etc.
• Operates and maintains various scientific instrumentation such as High Performance Liquid Chromotatography (HPLC), Fournier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA), and Differential Scanning Calorimeter (DSC), etc.
• Assist in the planning an executing activities associated with prototype formulation design, process development, scale-up and technology transfer
Minimum Work Experience/Educational Requirements
• Knowledge and experience with proteins, with a wide variety of parenteral systems (syringes, vials, freeze drying, cold chain, etc.) utilized for formulation and filling of recombinant protein products and with the current practice of protein formulation and associated analytical techniques (MS, HPLC, SDS-PAGE, etc.) is desirable
• Ideal candidate will have strong analytical skills and experience with purification
• BS/MS in Chemistry, Pharmacy, Biochemistry, Analytical Chemistry, Formulation Science, etc., with 2 - 4 years experiences in formulation, bioanalytical protein development, and/or biopharmaceutical development
• Must sign a confidentiality and a non-compete agreement
Physical Requirements/Work Environment
• Majority of day spent on feet in the laboratory or clean rooms
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position
• Must be able to lift/push/pull 30 pounds
• May require Medical Surveillance testing
• Limited use of hazardous chemicals
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.
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...