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.
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