Senior Staff Engineer

Role: Senior Staff Engineer in Process Development specializing in downstream bioprocesses for biotherapeutics. Objectives include leading development, optimization, scale-up, and commercialization of purification, filtration, chromatography, viral clearance, and formulation processes, with a focus on platform strategies, process intensification, automation, PAT, and digital solutions. Responsibilities encompass technical leadership, cross-functional collaboration, external partnership management, and mentoring. Requirements: Bachelor’s (11+ years), Master’s (9+ years), or Ph.D. (3+ years) with extensive industry experience in cGMP pharmaceutical development, cGMP knowledge, and proven expertise in process development and technology implementation. Preferred skills include advanced data analysis, process modeling, automation, PAT, process intensification, and digital infrastructure development. High-value specifics involve experience in biotherapeutic manufacturing, process development for biologics, and leadership in cross-disciplinary teams within a regulated environment. Location: Lexington, MA, full-time, onsite with no specified travel. The role demands technical excellence in bioprocessing, regulatory understanding, and strong collaboration with development, manufacturing, quality, regulatory, and external partners.