Process Development & Manufacturing Manager, Biotech – Stream Biomedical

Stream Biomedical is an early stage company founded to address unmet therapeutic needs for individuals suffering as a result of neurologic trauma and/or degeneration. We are seeking a Process Development & Manufacturing Manager, Biotech to support development activities. Candidate should be entrepreneurial, resourceful and interested to work with multiple internal and external disciplines. Candidate should appreciate the opportunity to work in a small company with growth potential. If you are eager to make an impact in a therapeutic area with great unmet need, please submit a CV/resume to HR@streambiomed.com for consideration.

Qualifications

  • BS Biochemistry, Chemistry or Chemical Engineering minimum, PhD preferred
  • Demonstrated recombinant protein/peptide processing and purification experience is required – all others will NOT be considered. Hands-on experience strongly preferred.
  • Experience with prokaryotic and/or eukaryotic expression systems for the large-scale production of recombinant proteins. Systems may include E. coli, CHO, HEK293, Baculovirus, Saccharomyces, or Pichia pastoris.
  • Experience with commonly utilized column chromatography methods used for protein purification, including ion exchange, HIC, SEC, IMAC and other affinity media.
  • Experience with commonly utilized analytical techniques for assessment of protein quality, including quantitative protein assays (e.g., Bradford, BCA), SDS-PAGE, ELISA, Western blotting, analytical SEC, and spectroscopy.
  • Industry experience in a GMP environment preferred

Responsibilities

  • Support planning and coordination of recombinant protein process development
  • Support development of analytical methods and batch release criteria
  • Collaborate with internal and external resources to develop, troubleshoot and specify molecular biology, expression and purification parameters to optimize yield while ensuring bioactivity
  • Coordinate with consultants and contract development and manufacturing organizations to scale process in compliance with FDA GMPs as required
  • Perform ad hoc experimentation as required
  • Write protocols, reports, specifications and SOPs

Skills, Capabilities, Experience

  • Ability to develop productive collaborations with internal and external resources
  • Ability to understand, communicate and implement the science
  • Working knowledge of statistical analysis
  • Working knowledge of biologic GMPs and FDA Guidance
  • Able to work independently and with internal and external resources including consultants and contract firms
  • Strong computer skills including Microsoft Word, Excel, PowerPoint
  • Must be resourceful
  • Must be a problem solver
  • Must have strong verbal and written skills

Desired Experience:

  • CD-Spectropolarimetry and FTIR for characterization of secondary structure
  • Peptide mapping via Mass Spectrometry
  • SPR for determination of binding affinity