Research Associate Analytical Development/GMP manufacture

Company Overview

Vedanta is pioneering the development of a new class of therapies that act by modulating the composition of the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune, infectious, and metabolic diseases in ways that are completely different from 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 Ventures and a team of world renowned experts in immunology and microbiology. Position Description / Responsibilities Vedanta is looking for a talented Process Development (PD) Engineer. The candidate will set up and be responsible for the execution of process development experiments, including medium development, generation and characterization of cell banks, small scale fermentation and scale-up, cell separation, and lyophilization.  The candidate will also be involved in the manufacture of clinical supplies.

The candidate will: 

  • Work closely with the discovery team to map the characteristics of Vedanta’s live biotherapeutic products and develop processes to manufacture them at scale.  
  • Establish the critical fermentation, harvest and lyophilization conditions for live biotherapeutic products.  
  • Be responsible for running the Process Development laboratory on a day to day basis, including being responsible for maintaining adequate supplies, equipment selection and maintenance, and liaising with suppliers of process development equipment.
  • Liaise with Quality Assurance and Control to ensure GMP compliance and be responsible for writing Batch Manufacturing Records for clinical manufacture.
  • Help recruit and mentor additional process development team members. 

The job title and level will be corresponding to work experience, education level, and skills of the selected candidate. 

Qualifications

  •  7+ years of relevant experience in the pharmaceutical or biotech industry or in a Contract Manufacturing Organization.
  • Role is best suited for a PhD with research experience in microbiology, bioprocess engineering, and work experience in Process Development.
  • Track record in supporting process development activities and executing production processes, preferably including experience with live biotherapeutics or live vaccines. 
  • Track record in medium optimization, preferably working with anaerobes, and experience in fermentation of anaerobes and primary processing.
  • Entrepreneurial and self-motivated work style.

 

If you are interested in applying for this position, please submit resume and cover letter at puretechhealth.com