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 development and implementation of method transfer, qualification and validation activities for clinical and commercial client projects.
Essential Job Functions/Duties
• Function as lead analyst for method transfer, qualification or validation activities, as applicable
• Provide non-compendial raw material validation support
• Provide project updates to Method Transfer Team Coordinator
• Provide technical peer review of analytical testing data associated with method qualification, transfer or validation
• Write/revise/review technical documents including method transfer protocols, procedures and summary reports
• Provide technical support as needed to other functional areas within QC as well as other departments
• Accurately complete necessary documentation
• Train Quality Analysts on laboratory methods and instrumentation
• Follow all established laboratory, regulatory, safety, and environmental procedures
• Adhere to the standards of quality ruled by current GMP, company Quality Policies and site SOPs
Minimum Work Experience/Educational Requirements
• Previous experience validating and/or transferring analytical methods in a GMP environment
• Strong technical writing skills required
• Proficiency with Word, Excel, is desired as well as general computer proficiency is required
• Excellent attention to detail
• Strong written and verbal communication skills to effectively communicat
• BS in analytical chemistry, life sciences or related field is required, or equivalent 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
• 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
• This position works with hazardous chemicals regularly
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 - 23 months ago
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...