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Scientist, Formulation 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 a formulation and lyophilization specialist to join the Process and Analytical Development Group, supporting ongoing early and late stage process development efforts for stabilization and 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. The job title and level will correspond to the experience and skills of the selected candidate.
 
Here’s What You’ll Do:
  • Provide technical expertise on formulation development and stabilization methods for LBPs, such as lyophilization and spray drying
  • Conceptualize and perform formulation process development and optimization studies in support of new product development (Phase 1/2)
  • Support ongoing manufacturing process improvements and process characterization for late stage programs (Phase 2/3/BLA)
  • Help identify and vet novel stabilization approaches including research, vendor management, experimental testing, and providing recommendations
  • Collaborate and coordinate across and within functional areas, including process and analytical development and manufacturing groups
  • Role is primarily lab-based, with opportunities to manage/mentor junior team members (TBD based on selected candidate)
  • Maintain excellent technical records, write technical development reports, contribute to regulatory filings, and communicate progress regularly to functional and program teams
Requirements:
  • MS/PhD in chemical engineering or related field with 4+ years of relevant experience, BS with 6+ years of relevant experience
  • Experience with formulation and lyophilization of LBPs preferred, but curious and open minds with strong technical experience in protein biologics or vaccines welcome
  • Expertise in lyophilization cycle optimization, formulation development for long term product stability, scale up considerations, and knowledge of phase appropriate process development required
  • Experience with regulatory filings, working with clinical team members to finalize drug product formulation design, and previous drug development experience highly preferred
  • Individual contributors as well as 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.
  • Strong technical writing, communication, and presentation skills are required.
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