Group Lead R&D Fermentation Bioprocess-USFDA

Job Description

BE Biosol Pvt Ltd is hiring for #Group Lead #R&D Fermentation #Bioprocess-USFDA Approved plant, Shamirpet location, Hyderabad. Qualification:PhD/M.Sc/M.Tech Experience: 12 to 17 years Job Description BE Biosol is seeking an experienced Fermentation & Bioprocess Development to lead upstream and downstream process development programs spanning microbial fermentation products and biologics. This role will be instrumental in establishing world-class R&D, pilot-scale and future commercial manufacturing capabilities for APIs, while supporting the organization’s expansion into monoclonal antibodies (mAbs), biosimilars and recombinant biologics. Key Responsibilities: * Lead bacterial fermentation process development from cell banking, seed development and shake flask studies through pilot-scale fermentation. * Drive process optimization using advanced understanding of fermenter fluid dynamics, oxygen transfer, mixing, scale-up, metabolism and process engineering principles. * Apply advanced Design of Experiments (DoE), Quality by Design (QbD), statistical modelling and metabolomics to improve productivity, robustness and process understanding. * Lead downstream process development, optimization and scale-up including harvest, filtration, TFF and chromatography to achieve target yields, recoveries and impurity profiles. * Provide scientific leadership for future mAb and biosimilar process development, pilot manufacturing, technology transfer and commercial readiness activities. * Support establishment of greenfield R&D and pilot manufacturing facilities, including equipment selection, process design, commissioning and technology transfer. * Lead cross-functional teams, mentor scientists and engineers, and drive a culture of innovation, scientific excellence and execution. Candidate Profile * PhD / M.Tech / M.Sc. in Biotechnology, Biochemical & Bioprocess Engineering, Microbiology. * Hands-on industrial experience in fermentation, bioprocess development and scale-up. * Proven expertise in microbial fermentation, process characterization, pilot plant operations and downstream purification. * Strong knowledge of fluid dynamics, fermentation engineering, metabolomics, PAT tools, DoE and statistical analysis. * Experience in development and scale-up of APIs or related fermentation-derived products. * Exposure to mAbs, biosimilars, single-use technologies and biologics manufacturing will be highly preferred. * Demonstrated success in technology transfer, team leadership, problem-solving and decision-making in a complex R&D environment. Key Competencies * Scientific and technical leadership * Analytical and critical thinking * Data-driven decision making * Hands-on troubleshooting and process optimization * Team building and stakeholder management * Greenfield project execution and scale-up expertise

Interested aspirants with relevant skills set can share their resumes to Mahesh.Patsamatla@bebiosol.com with Subject Line “Application for RDFB – Lead Role