Manager; Technical Services, Drug Substance - 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 initial project evaluation, project transfer, and product scale up and to partner with project management, marketing, development, clients, and manufacturing to facilitate technical transfer and product manufacturing.
ESSENTIAL JOB FUNCTION/DUTIES
• Partner with Business Development and Project Management to understand capacity demands

• Partner with Process Development to understand timing of laboratory and technical transfer activities

• Partner with Operations to understand timing of processing activities as well as planned and unplanned maintenance requirements

• Partner with Technical Services Scientists to associate the process orders with Bills of Material and consumables

• Ensure effective use of material, equipment and personnel in production of quality products

• Approve procedures, specifications and activities in manufacturing department

• Effectively communicate with all levels of the organization as well as with customers and suppliers

• Provide leadership for technical services group

• Participate in manufacturing site audits (Technical and/or GMP) as required

• Develop batch records for manufacturing execution

MINIMUM WORK EXPERIENCE/EDUCATIONS REQUIREMENTS
• Excellent communication, teamwork, and technical writing skills

• Exceptional analytical and problem-solving skills

• Ability to prioritize individual and team workload to meet deadlines

• Demonstrated ability to lead and manage a team

• Demonstrated ability to work cross functionally

• Effectively communicate (verbal and written) across various functions

• Training and/or experience in technical Project Management

• Bachelor’s degree in life sciences, engineering, applicable discipline or equivalent work experience; master’s degree or Ph.D. in related field preferred

• 8 years experience in manufacturing or a commensurate level of experience with related animal cell culture and associated purification of biologics preferred

• 5 years of supervisory experience preferred
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
• Must be able to lift/push/pull up to 50 pounds occasionally

• Potential exposure to hazardous chemicals

• Ability sit for long periods to work on a computer

• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position

• Ability to stand for long periods

• Must be able to work in an environment that can affect an electronic implant device (i.e. pacemaker, auto injector, etc.)

• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in areas associated with this position

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