Senior Process Engineer

Title:                   Senior Process Engineer

Location:           Cambridge, MA

Reports to:        Associate Director, Technical Operations

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

The Senior Process Engineer will be responsible for working cross-functionally to design, scale, and implement processes in Vedanta’s manufacturing facilities. This individual is a motivated and experienced process engineer and will focus on operations support, project execution, and tech transfer. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for an enthusiastic and innovative individual with a good understanding of late-phase projects from a technical and compliance standpoint. An understanding of phase-appropriate approaches and how to effectively scale operations are required.

Here’s What You’ll Do:

• 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.

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.