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Senior 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 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. The job title and level will correspond to the experience and skills of the selected candidate.
 
Here’s What You’ll Do:
  • Execute and optimize microbial analytical methods including but not limited to: cell plating/growth recovery, liquid culture/fermentation, viable/total cell counting, and biological potency assays
  • Lead and manage laboratory projects including designing, overseeing, and executing experimental plans, timeline, budgets, and team/resource management of multiple levels of scientists and multiple instruments/lab space
  • Help identify and vet novel analytical approaches/methods/technologies 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/method transfer to internal groups and external vendors as needed
  • Evaluate and improve method execution and performance, including qualification and validation efforts for GMP and non-GMP settings
  • Review and approve data with a preference for disposition on OOS/OOT and laboratory investigations including root cause analysis/CAPA implementation
  • Collaborate and coordinate across and within functional areas, including process and analytical development and manufacturing groups, serving as subject matter expert
  • Maintain excellent technical records, contribute to regulatory filings, and communicate progress regularly to functional and program teams
 Requirements:
  • PhD in microbiology, biology, biochemistry, or related field with completion of postdoctoral work and 3+ years of relevant pharmaceutical/analytical development experience. MS candidates with 10+ years of relevant pharmaceutical/method development experience may be considered
  • Demonstrated experience advancing projects with track record of peer-reviewed publication or IND support
  • Diverse background of in vivo and in vitro scientific expertise in areas such as but not limited to: microbiology, immunology, molecular biology (PCR/qPCR), cell biology (flow cytometry, microscopy), executing and developing quantitative and qualitative biological assays. Experience with NGS and other cell-counting methodologies a bonus.
  • Experience in microbial assay development and qualification in a drug development setting preferred, GxP expertise required
  • Experience with anaerobic microbial consortia (LBPs) preferred
  • Knowledge of current state of method development for characterization of microbial consortia (LBPs) preferred
  • Experience with phase-appropriate quality attribute specification setting highly preferred
  • Familiarity with FDA and EMA guidance relevant to pharmaceutical development (analytical), LBP experience a bonus
  • Previous direct report management and mentoring of more junior scientists
  • Ability to operate independently as scientific lead for data interpretation, packaging, and presentation
  • Highly organized and motivated. 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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