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Sr. Scientist, Fermentation Process Development

Cambridge, MA · Science/Research
At Synlogic: We are Putting LIFE Into Medicines.
 
We are pioneers in the development of Synthetic BioticTM medicines, a novel class of LIVING medicines intended to transform the lives of patients with a broad range of diseases ranging from genetic and acquired metabolic diseases to inflammation and cancer. 
 
Every day our teams work tirelessly to drive to deliver on 4 aspirations:  
  • People:  LIVING each day with passion for building up and building out our Synlogic team
  • Platform:  Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
  • Products:  Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
  • Promise:  Building our company to launch multiple novel LIVING medicines mastering a new frontier in medicine
 We combine Human Logic and Science Logic to drive meaningful work, careers, and LIFE at Synlogic. We foster a people-focused environment grounded in:  Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire:  Innovation, Integrity, High Performance, and LIFE Changing Results.
 
We continue to build and enhance our organization. If you want a settled environment, pursuing a well-walked path then this environment is probably not for you.  If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you. 
 
POSITION SUMMARY:
 
We are seeking a highly motivated and enthusiastic scientist to drive development of microbial fermentation processes for manufacturing of the synthetic biotics. Reporting to the Head of Bioprocess Development, this individual will lead a team responsible for development of robust and scalable microbial fermentation processes for late-phase clinical manufacturing. 
 

Primary responsibilities include:

  • Lead and contribute to lab operations to support microbial fermentation process development, improvement, and validation
  • Identify technical strategies and design scale-down studies to provide a data-driven approach to process optimization and resolution of process deviations
  • Provide technical insight into experimental design and perform data analysis using analytical tools such as JMP, MiniTab or Spotfire
  • Manage phase III and commercial process development activities, including FMEA risk assessment, screening studies, design of experiments (DOE), and process characterization, Process Analytical Technology (PAT), In Process Control (IPC) Strategy, Process Performance Qualification (PPQ)/Process Validation Runs
  • Provide support for tech transfer, process characterization, process validation and manufacturing campaigns
  • Contribute to preparation of reports and documents required for regulatory submission
  • Represent the bioprocess development group through oral and written communication within the organization and to external organizations
Qualifications and experiences:
  • Degree in Chemical/Biological Engineering, Microbiology, Biotechnology or relevant scientific or engineering field; MS with 10+ years, PhD with 5+ years of relevant experience
  • Previous successful technology transfer and experience in bioprocess engineering and/or commercial manufacturing
  • Experience in Phase III or commercial PD of a biologic (protein/antibody/enzyme or a Live biotherapeutic product) desirable
  • Experience working with perfusion bioreactors (ATF or TFF) for high cell density cultures desirable
  • Familiarity and hands-on experience with analytical methods typically used in the manufacture and characterization of cell-based products
  • Knowledge of downstream unit operations (centrifugation, tangential flow filtration, and various chromatography systems)
  • Prior experience with leading projects and mentoring technical staff
  • Must have strong verbal and written communication skills
  • Must be flexible and able to work well within a fast-paced, dynamic and team-oriented environment
To learn more about us, visit www.synlogictx.com
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