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 serve as an upstream technical representative for the Technical Service group during potential client visits and client audits.
• To support the technical transfer process, investigations, and batch record generation for cGMP manufacturing and to partner with internal and external clients to design and support manufacturing processes.
Essential Job Funtion/Duties
• Plan and participate in manufacturing site audits (Technical and/or cGMP) as required
• Participate potential client visits as required
• Lead technical transfer in conjunction with the development laboratory, manufacturing, and quality assurance
• Generate electronic batch records
• Provide floor support during critical operation steps
• Lead level II investigations and recommend corrective/preventive actions for ongoing manufacturing processes
• Write manufacturing campaign report
• Develop strong relationships with clients
• Quickly identify and resolve upstream manufacturing issues
• Must work and interact effectively with and for others to achieve
• 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
• Must be able to manage multiple tasks and/or priorities and easily adapt to changing situations
• Experience with upstream process development and/or tech transfer
• Experience with upstream manufacturing operation
• Technical understanding of bioreactor design and scale up
• Excellent problem solving and investigational skills
• Excellent communication skill
• 8 or more years experience in GMP upstream manufacturing of biopharmaceutical products or a commensurate level of experience with related products
• BA/BS degree in life sciences, engineering, or other applicable discipline or equivalent industry experiences, graduate degree preferred
Physical Requirements/Work Environment
• Must be able to lift/push/pull up to 30 pounds occassionally
• Ability to sit for periods of time while working on the computer
• Potential limited exposure to hazardous chemicals
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes will be required in areas associated with this position
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...