Senior Process Engineer

3 weeks ago

Cambridge, United States TBWA\Chiat\Day Full time

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 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. 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. Support PAI preparation and inspection. Participate in day-to-day Tech Transfers including manufacturing support and compliance. 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. Drive results on multiple complex assignments, reviewing and guiding the work of vendors/consultants. Contribute to decisions based on professional judgement, experience, budget, cGMP regulations, and ethical guidelines. Stay current with relevant technologies and identify new approaches. 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. Prior PV work highly desired. Ability to thrive within a fast-moving, dynamic environment. Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. #J-18808-Ljbffr

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