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 provide quality control testing of raw materials according to SOPs, cGMPs and regulatory guidelines.
ESSENTIAL JOB FUNCTION/DUTIES
Perform and review analytical chemistry testing during phases of production that include incoming raw material ID and release testing
Provide technical peer review of analytical testing data
Write/revise technical documents including laboratory procedures, protocols and technical reports
Independently utilize sophisticated analytical instrumentation such as HPLC, GC, UV, ICP-MS, FTIR, TOC
Perform biochemical analyses using methodologies such as SDS-PAGE, western blotting, IEF, ELISA, ELLA, mammalian cell culture, IP, CE
Act as department lead on projects and laboratory investigations
Recognize atypical/out of specification (OOS) results and perform investigation to determine root cause and implement corrective and preventive actions (investigations are to be completed within 30 days of initiation)
Develop and execute validation and transfer protocols for new methodology
Accurately complete necessary documentation
Interpret and apply US and EU regulations as they apply to the analytical laboratory and production facility
Perform training on laboratory methods and instrumentation
Maintain laboratory records and primary data in accordance with applicable regulations and company policy
Utilize computerized systems such as LIMS and CDS for generating/compiling data
Follow all established laboratory, regulatory, safety, and environmental procedures
Calibrate, operate and maintain a variety of lab instrumentation
Adhere to the standards of quality ruled by current GMP and the company
MINIMUM WORK EXPERIENCE/EDUCATIONS REQUIREMENTS
Strong written and verbal communication skills to effectively communicate with co-workers as well as management
Excellent attention to detail
Ability to work independently
Strong analytical and investigative skills
Strong work ethic, dedication to safety and the desire to be part of a team
BS/BA in analytical chemistry, life sciences or related field is required, or equivalent work experience
2-4 years experience in analytical chemistry or the biotechnology/biopharmaceutical industry is desired
Ability to work weekends and off-shift hours as needed to support manufacturing activities
Required to sign a confidentiality and a non-compete agreement
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
Majority of day spent on feet in the analytical chemistry laboratory
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
Use of hazardous chemicals on a regular basis
Must be able to lift/push/pull up to 30 pounds on a consistent basis
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 - 5 months ago
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