Senior Scientist, Cell Culture Development - Cook Pharmica
Cook Medical - Bloomington, IN

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PURPOSE, OBJECTIVES, FUNCTIONS:
· To conduct laboratory and pilot plant experiments to develop and improve bioreactor processes, media, cell lines, and operations.
· To develop a thorough understanding of the techniques and process and applies the technical knowledge to develop and implement a process, such that it is suitable for manufacturing.
· To execute internal and external client experimental plans in support of contracted work.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Essential Functions:
  • Design, supervise and evaluate laboratory experiments
  • Develop economical and robust expression paradigms for recombinant proteins, through media development, cell line development and bioreactor process development
  • Mentor junior staff members in laboratory techniques and procedures
  • Provide initial interpretation of data and suggests next experimental steps
  • Support process transfer into manufacturing and process validation at scale
  • Identify process parameters for bioreactor and cell line development, and the necessary experimental analysis
  • Maintain necessary documentation including process development reports, technical transfer reports, and process related documentation

Additional Responsibilities:
  • Establish a process control strategy and assist in the identification and resolution of manufacturing problems using a sound scientific and statistical methodology
  • Assist in process improvements that may be of value to the client
  • Write and revise protocols, procedures, reports and other process related documentation as necessary to support the client and manufacturing operations
  • Act as technical lead for client projects, providing technical insight and guidance to internal and external clients

AUTHORITIES:
  • Identify and report any preventative maintenance needs
  • Identify potential hazards either safety or ergonomic
  • Place purchase requisitions for laboratory members
  • Identify, suggest and implement any process improvements

EMPLOYMENT REQUIREMENTS:
  • Requires a BA/BS in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline or equivalent work experience and 6-8 years directly relevant experience in the biopharmaceutical environment
  • MS in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline or equivalent work experience and 4 years directly relevant experience in the biopharmaceutical environment
  • PhD in Biochemistry, Cell Biology, Microbiology, Chemical Engineering or related discipline with minimum of 2 years directly relevant experience to the biopharmaceutical environment
  • Required to sign a confidentiality and a non-compete agreement
  • Experience with cGMPs desirable

POSITION QUALIFICATIONS:
  • Extensive knowledge of laboratory procedures and operations
  • Extensive knowledge and experience with cell culture techniques, protein expression, cell culture scale up, and associated analytical techniques required
  • Excellent written, oral and organizational skills
  • Required licenses and certificates
  • Must have strong analytical skills and experience with cell culture
  • Must have appropriate laboratory experience/training as well as a strong mechanical aptitude
  • Must be results-oriented with a hands-on attitude in a fast-paced multiple-project environment
  • Strong attention to detail
  • Strong problem solving skills
  • Must be able to work independently and be able to prioritize activities
  • Strong interpersonal skills (both verbal and written)

ACCOUNTABILITY:
· Responsible for completing assigned tasks by due dates
· Responsible for training curriculum on current SOPs
· Responsible for documenting, reviewing and/or verifying laboratory data
· Responsible for compliance to company’s Quality Policy Manual
· Responsible for compliance with company’s safety policies
· Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook
· Responsible for compliance of Corporate Code of Conduct

PHYSICAL REQUIREMENTS AND ENVIRONMENTAL CONDITIONS:
  • 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

This description is not intended to provide an all inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. T his job description is not a contract of employment and does not change your status as an at-will employee.

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 - 17 months ago - save job - block
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Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...