Process Development Engineer at Catalent in Chelsea, MA

Summary: Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and they are seeking a Process Development Engineer. This role involves developing pharmaceutical processes, technology transfers, and scale-up of spray-drying and capsule filling processes, while ensuring compliance with Good Manufacturing Practices. Responsibilities: - Responsible for the start-up, troubleshooting and process development of late phase tech transfer, scale-up and pre-commercial manufacturing - Supports process development activities and is responsible to set-up and run experiments on GMP manufacturing equipment - Conducts analysis of development data and provides recommendations for future experimental designs - Participates in the assembly, operation, disassembly and cleaning of equipment. Assists manufacturing operations with validation of new processes as needed - Responsible for the evaluation of critical process data and drives the process development life-cycle - Provide technical support to other areas including spray drying, secondary drying, process engineering, QC, and QA - Understand Quality by Design approaches and conduct modeling exercises to better understand process development. Manages and coordinates individual projects (internal and external) as needed - All other duties as assigned Required Qualifications: - Bachelor's Degree in Chemical, Biomedical Engineering or Pharmaceutical Sciences (or related field) required - Must have at least one (1) year of relevant industry experience, preferably in biotechnology/pharmaceutical R&D - Prior experience with dry powders for inhalation, specifically in the areas of particle engineering of dry powders, blending and capsule filling - Strong statistical background with knowledge of Design of Experiments (DoE) preferred - Must be proficient in Microsoft Office Suite - Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities - Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds Preferred Qualifications: - Master's Degree is a plus - Knowledge of Quality by Design, cGMP and modelling is a plus - Minitab or JMP is a plus Required Skills: Process Development, GMP Manufacturing, Dry Powder Inhalation Important Skills: Design of Experiments, Statistical Analysis, Microsoft Office Suite Nice-to-Have Skills: Quality by Design, Technical Support, Project Management Benefits: Defined career path and annual performance review and feedback process, Diverse, inclusive culture, Positive working environment focusing on continually improving processes to remain innovative, Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives, 152 Hours + 8 paid holidays, Several Employee Resource Groups focusing on D&I, Dynamic, fast-paced work environment, Community engagement and green initiatives, Generous 401K match, Company match on donations to organizations, Medical, dental and vision benefits effective day one of employment, Tuition Reimbursement – Let us help you finish your degree or start a new degree!, WellHub program to promote overall physical wellness, Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories