logo

View all jobs

Head of Process 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

Vedanta is seeking a talented Head of Process Development. This role will direct the planning, execution, and reporting of all process and optimization activities for process development workflows and initiatives. The individual will provide strategic and operational leadership for the process development team, as well as directing 3rd party vendors, as needed. The Head of Process Development is tasked with developing and improving robust and scalable manufacturing processes, scientifically sound specifications, and in-process controls. Both a leader and an expert, this individual will leverage their experience with microbial fermentation, TFF harvest, formulation, lyophilization and solid dosage form filling to provide exceptional process development services and innovations.

The ideal candidate is passionate about process development, has demonstrated success in leading and managing process development within a CGMP setting, and will be assessed equally for their people management skills and for their technical abilities.

Here’s What You’ll Do:

  • Provide strategic leadership for process development and engineering within the organization, and as needed for the expansion of internal and external capabilities
  • Oversee the development, optimization, and scale up of Drug Substance and Drug Product processes as they transfer to CGMP manufacturing.
  • Plan timelines and budgets related to all development activities, including: fermentation, TFF, formulation, lyophilization, milling, and capsule fill.
  • Ensure the team delivers robust, scalable, and scientifically sound processes in support of Vedanta’s therapeutic products
  • Establish standards and processes to ensure that the process development and validation activities are performed in a consistent and rigorous manner consistent with current FDA / industry guidance
  • Evaluate new cutting-edge technologies relevant for the advancement of the platform process
  • Collaborate with executive and functional leaders to ensure alignment on deliverables
  • Effectively manage and motivate a team to deliver high-quality work that moves the business and science of Vedanta forward
  • Perform technical writing for regulatory submissions

Requirements:

  • BS in chemical engineering, biochemical engineering, or similar field with 10 years of relevant biotech experience; MS with 8 years of relevant biotech experience; OR PhD with 5 years of relevant biotech experience.
  • Previous experience in CGMP is required.
  • Experience with microbial fermentation technologies, formulation, and upstream processing is essential. Experience with anaerobic bacteria is a plus.
  • Prior experience and demonstrated success in managing a team of engineers and scientists
  • Must have a proven track record of leadership, people management, and effective interpersonal and communication skills
  • Possess a “can-do” attitude with a focus on team success. Must be able to successfully navigate a start-up environment and build strong cross-functional relationships.

Why join Vedanta Biosciences

Vedanta is pioneering the development of a new class of therapies 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. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Our Vision:

We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia

Powered by