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Scientist, Analytical Development

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role
 
We are looking for an analytical development specialist to join the Process and Analytical Development Group, supporting ongoing early and late stage analytical development efforts for production of Vedanta Biosciences’ portfolio of Live Biotherapeutic Products (LBPs). Vedanta is developing defined bacterial consortia LBPs to treat intestinal pathogen infections, cancer, allergy, and inflammatory bowel diseases. We are looking for an individual who is independent, curious, self-motivated, excited to collaborate, and an excellent communicator.
 
Here’s What You’ll Do:
  • Provide scientific expertise on optimization and execution of microbial analytical methods such as cell plating, viable cell counting, qPCR, and biological potency assays
  • Help identify and vet novel analytical approaches for characterization of microbial consortia for use in drug development
  • Develop and qualify analytical methods, write development reports, author SOPs, and collaborate with QA/ QC on tech transfer to external vendors as needed
  • Contribute to the establishment of clinical phase-appropriate specifications and control strategies for starting materials, drug substance, and drug product
  • Collaborate and coordinate across and within functional areas, including process and analytical development and manufacturing groups
  • Primarily lab-based with one junior associate currently reporting to this role (yet to be hired)
  • Maintain excellent technical records, contribute to regulatory filings, and communicate progress regularly to functional and program teams
Requirements:
  • MS/PhD in microbiology, biology, biochemistry, or related field with 2+ years of relevant pharmaceutical analytical development experience, BS with 6+ years of relevant experience
  • Expertise in microbial assay development and qualification in a drug development setting required
  • Core expertise: microbiology, method development/qualification for accuracy and precision, CFU/mL cell counting assay optimization, qPCR probe design and assay development, biological assay development, bonus: NGS, flow cytometry, other cell counting methodologies
  • Experience with anaerobic microbial consortia (LBPs) preferred
  • Knowledge of current state of method development for characterization of microbial consortia (LBPs)
  • Experience with phase-appropriate quality attribute specification setting highly preferred
  • Familiarity with FDA and EMA guidance relevant to LBP pharmaceutical development (analytical)
  • Those looking to grow into a scientific leadership role without leaving the lab are encouraged to apply
  • Highly organized and motivated individual. Must be a team player, able to work well in a group setting as well as independently in a fast-paced environment. Able to manage workload based on changing priorities while maintaining attention to detail.
  • Strong analytical, problem solving and critical thinking skills
  • Strong technical writing, communication, and presentation skills
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