Principal Scientist, Purification Development - Cook Pharmica
Cook Medical - Bloomington, IN

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PURPOSE, OBJECTIVES, FUNCTIONS:
· To technically understand, develop and improve purification processes and operations, adhering to customer, regulatory, safety and environmental requirements and guidelines.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Essential Functions:
  • Design, evaluate, and develop systems to purify recombinant proteins
  • Develop new "tools" by investigating and evaluating new technologies for process improvement or future use
  • Develop a thorough understanding of the process and apply technical knowledge to develop or adapt a process
  • Establish a process control strategy and assist in the identification and resolution of manufacturing problems using sound scientific and statistical methods while working with a diverse group of people from manufacturing and various support groups
  • Design, supervise and evaluate laboratory experiments that support plant trials using statistical thinking
  • Maintain necessary documentation including process development reports, technical transfer reports, and process related documentation

Additional Responsibilities:
  • Design and develop 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
  • Develop staff to maximize team and company goals
  • Interpret data, prepare reports and present results to the project teams
  • Manage technical oversight over purification operations

AUTHORITIES
  • Generate novel approaches to the development of commercially viable purification processes
  • Identify and report any preventative maintenance needs
  • Identify potential hazards either safety or ergonomic
  • Place purchase requisitions for laboratory members
  • Identify and suggest and test any process improvements
  • Coach, counsel and discipline direct reports as appropriate

EMPLOYMENT REQUIREMENTS:
  • Ph.D. in Biochemical Engineering, Chemical Engineering, Molecular Biology, Biochemistry, or related area or equivalent
  • 8+ years of academic or industrial experience (subsequent to a postdoctoral fellowship) studying or working with a wide variety of systems (HPLC, CE, MS, ELISA, CD, DLS, SLS, DSC, etc.) suitable for analyzing protein products and is experienced with the current theory and practice of protein characterization
  • Must sign a confidentiality and a non-compete agreement

POSITION QUALIFICATIONS:
  • 5 years supervisory experience preferred
  • Must have strong analytical skills and experience with purification
  • Must have appropriate laboratory experience/training as well as a strong mechanical aptitude
  • Exhibit strong leadership abilities and strong interpersonal skills
  • Must also be independent, multi-tasking and results-oriented with a hands-on attitude in a fast-paced and energetic start-up environment
  • Thorough understanding and practical experience in manipulation and analysis of DNA and RNA for industrial applications
  • Knowledge and experience with purification techniques and associated analytical techniques gained through industrial experience
  • Experience with cGMP- regulated environment desirable
  • Excellent written, oral and organizational skills
  • Skillful in purification development (IEX, SEC, affinity chromatography, HIC, etc.)
  • Skillful in statistical design of experiments
  • Experience with cell culture and product recovery
  • Strong interpersonal skills (both verbal and written)

ACCOUNTABILITY:
  • Responsible for performing experiments in a timely manner to align with client timelines
  • Responsible for training curriculum on current SOPs
  • Responsible for documenting, reviewing and/or verifying laboratory data
  • Responsible for the initiating and completing investigations in a timely manner
  • 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
  • Responsible for employment decisions

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.

About this company
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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...