Process Development Scientist I - Upstream

Company: KBI Biopharma Inc.
Location: Durham
Posted on: May 27, 2023

Job Description:

Position Summary:

KBI Biopharma seeks to fill a role for Cell Culture Process Development Scientist. This person will lead and assist in cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.

Position Responsibilities:

• Supports product development efforts in the process and manufacturing areas.
• Conceptualizes and proposes process development and manufacturing based on biopharmaceutical data.
• Provide technical support for clinical manufacturing and product testing.
• Works toward developing a broad knowledge of state of the art scientific principles, theory of cGMP and other regulatory requirements.
• Act as spokesperson on development programs and interact positively and productively with clients.
• Lead and support the team in the set-up, operation, and associated analysis of cell culture and bioreactor processes including bioreactor preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis for shake flask and various scale bioreactors (ambr15, ambr250, 3 L & 15 L glass bioreactors, 50 L and 200 L Xcellerex single-use bioreactors).
• Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors. Required to perform calculations for growth date, specific productivity, bioreactor agitation and gassing scale-up.
• Maintains a cell culture-specific project plan, including raw materials and equipment availability, in preparation of laboratory and pilot- scale runs.
• Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
• Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
• This is an on-site position.
  
  Minimum Requirements:
  
  Degree within Chemical Engineering, Biotechnology or related area:
  
  • Bachelor's degree with 6+ years' experience
  • Master's degree with 4+ years' experience
  • Ph.D. with 0-2 years' experience
    
    Additionally, working knowledge of mammalian cell culture is required.
    
    Salary:
    
    $90,000 - $105,000 + premium
    
    Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
    
    KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.
    
    KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
    
    I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
    
    I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Keywords: KBI Biopharma Inc., Durham , Process Development Scientist I - Upstream, Other , Durham, North Carolina