Associate Scientist, Analytical Method Development - Cook Pharmica
Cook Medical - Bloomington, IN

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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.

Primary Function
To support the Principal Scientist in developing and improving analytical assays used to characterize intermediates and products, adhering to customer and regulatory requirements and guidelines.

Essential Job Function/Duties
• Assist in the development or implementation of analytical assays and systems
• Partner with purification scientists to establish methodologies suitable for a process control strategy
• Identifying process impurities and contaminants and conducting experimental analyses using DOE
• Support process transfer into manufacturing and process validation at scale for clinical production
• Co-author development and campaign reports
• Support the manufacturing process and cGMP
• Maintain necessary documentation including process development reports, technical transfer reports, and process related documentation
• Must work and interact effectively with and for others to achieve
company goals
• Must strictly adhere to safety requirements
• Must meet company attendance requirements
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various
levels of the organization
• Ability to work in collaborative and independent work situations and
environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

Minimum Work Experience/Educational Requirements
• General knowledge of laboratory procedures and operations
• Knowledge and experience with proteins, HPLC, HPIEX, HPSEC chromatography, and associated analytical techniques (HPLC, SDS-PAGE, etc.) is desirable
• Excellent written, oral and organizational skills
• Appropriate laboratory experience/training as well as a strong mechanical aptitude
• BA/BS/MS in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline or equivalent work experience
• 2–4 years related experience in industry
• Required to sign a confidentiality and a non-compete agreement
• Technically inquisitive, attention to detail and strong problem solving skills
• Able to work independently and be able to prioritize activities

Physical Work Experience/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
• Limited use of hazardous chemicals

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 - 14 months ago - save job - block
About this company
18 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...