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Manufacturing Investigator

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

The Manufacturing Investigator will play a key role supporting in-house CGMP manufacturing operations and ensuring the timely release of Vedanta Bioscience’s Live Biotherapeutic Products. The successful candidate should be self-motivated, have strong technical writing and project management skills, and be capable of working in a highly dynamic start-up environment.
 
Here’s What You’ll Do:
  • Manage the closure of deviations, CAPA, and change controls related to manufacturing operations.
  • Lead cross-functional investigation teams for complex/critical events.
  • Establish robust technical writing and investigation guidelines and training materials.
  • Monitor manufacturing deviation metrics to identify trends and continuous improvement opportunities.
  • Collaborate with key stakeholders to improve existing quality systems workflows.
  • Support system maturity projects for global late-phase clinical manufacturing.
Requirements:
  • Bachelor’s degree in a scientific discipline, engineering, or a related field.
  • 5+ years of experience in Quality Assurance, Manufacturing, or a technical support role.
  • Strong communication and technical writing skills. Prior experience authoring deviations, CAPA, and change controls preferred.
  • Solid understanding of relevant FDA/EMA/ICH quality requirements.
  • Experience with Veeva Vault QMS or similar software.
  • Strong analytical, organizational, and critical thinking skills.
  • Robust communication and technical writing skills.
  • Ability to work in a fast-paced setting and adjust to a changing environment.
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