Full-Time

Senior Process Engineer

Posted on 8/16/2024

Vedanta Biosciences

Vedanta Biosciences

51-200 employees

Develops microbiome-based therapies using bacteria

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • Engineering degree or equivalent required.
  • 5+ years of engineering experience in a biomanufacturing or development environment with 4+ years in a GxP environment preferred.
  • Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.
  • Prior PV work highly desired.
  • Ability to thrive within a fast-moving, dynamic environment. Embraces and drives change where appropriate.
Responsibilities
  • Support Process Validation (PV) activities including protocol and report authoring, review, and execution.
  • Review and execute Process Validation master plans and associated tasks.
  • Lead tech transfers within a multiple manufacturing site enterprise in support of high throughput/demand.
  • Assist process development with wet lab work performed as part of the FMEA pre-PV. Hands-on approach to gain understanding of the current process to be validated, in preparation for protocol development.
  • Support PAI preparation and inspection.
  • Participate in day-to-day Tech Transfers including but not limited to manufacturing, manufacturing support, and manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives.
  • Develop standardized documentation including SOP’s, training, validation of equipment, and reports.
  • Be a part of project teams in developing project and technology transfer strategy for both clinical and commercial manufacturing campaigns, including process validation and associated regulatory filings.
  • Drive results on multiple complex assignments, in addition to reviewing and guiding the work and performance of vendors/consultants.
  • Contribute to decisions based on professional judgement, experience, budget, cGMP regulations, and ethical guidelines of good business practices.
  • Must stay current with relevant technologies and be forward-thinking to identify new approaches. Future opportunity to help design commercial-scale facility to meet patients’ needs after launch.

Vedanta Biosciences focuses on developing microbiome therapies using groups of beneficial bacteria known as bacterial consortia. These consortia can colonize the human intestine and have the potential to treat various diseases. The company utilizes a proprietary discovery platform to identify and assemble these bacteria into effective therapeutic teams. Unlike many competitors, Vedanta has achieved commercial-scale production of its drug candidates while adhering to strict FDA regulations for safety and quality. The goal of Vedanta Biosciences is to transform disease treatment by providing new options for patients through its innovative approach to drug discovery.

Company Stage

Late Stage VC

Total Funding

$364.5M

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

0%

2 year growth

-1%
Simplify Jobs

Simplify's Take

What believers are saying

  • Fast Track designation for VE303 accelerates regulatory approval process.
  • Phase 3 RESTORATiVE303 study positions Vedanta as a market leader for rCDI.
  • Recent $106.5M funding round strengthens financial position and growth potential.

What critics are saying

  • Competition from Seres Therapeutics with FDA-approved C. difficile treatment.
  • High production costs may impact profitability and market reach.
  • Regulatory challenges due to unclear FDA guidelines for microbiome therapies.

What makes Vedanta Biosciences unique

  • Vedanta uses defined bacterial consortia for consistent therapeutic outcomes.
  • First to achieve commercial-scale CGMP production of bacterial consortia drugs.
  • Proprietary platform identifies and assembles optimal bacterial consortia for therapies.

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