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Manufacturing Supervisor

Cambridge, MA · Manufacturing
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
 
Position Description

Vedanta is seeking a highly skilled biopharmaceutical Manufacturing Supervisor for their Cambridge, MA manufacturing site. The position will be a key element to establish and operate Vedanta’s in-house CGMP manufacturing capabilities for Cell Banks, Drug Substance and Drug Product. This role will support the CGMP production of Vedanta’s Live Biotherapeutic Products (LBP), and will oversee a team of 5+ junior staff members. Applicants should be self-motivated, have strong communication skills, and be capable of working in a dynamic startup environment.

Hours are first shift.Occasional travel to Vedanta’s Acton, MA manufacturing facility may be required.

Here’s What You’ll Do:
  • Ensure the successful manufacture of Cell Banks, Drug Substance and Drug Product in a CGMP environment.
  • Assist with the facility startup and equipment qualification of a new late-phase clinical manufacturing suite.
  • Author and revise SOPs and Batch Records.
  • Own Manufacturing-related Deviations, CAPAs, and Change Controls.
  • Coordinate across functional areas to obtain production materials.
  • Collaborate with the Facilities to maintain process equipment.
  • Manage and implement continuous improvement initiatives within the manufacturing department.
Requirements:
  • BS in a scientific discipline or engineering.
  • 7+ years of hands-on experience with CGMP manufacturing.
  • 2+ years in a supervisory role.
  • Direct experience with cell banking, cell culture, fermentation, cross-flow filtration, lyophilization, and/or capsule filling.
  • Strong planning and organization skills.
  • Strong communication and technical writing skills.
  • Ability to work in a fast-paced setting and adjust to a changing environment.
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