Process Development Scientist

Company Description ZEO ScientifiX™ is a publicly traded biotechnology company based in South Florida, dedicated to the research, development, and manufacture of new cell-derived biologics. The organization focuses on current and emerging regenerative therapeutics, positioning itself as a fully integrated leader in biologic medicine. Full-time, onsite role. South Florida locals are encouraged to apply Role Description Work jointly with the Biologics Manufacturing and Research Manager on process development and validation procedures and activities. Complete Process Validations that are required as part of ZEO’s biologic manufacturing program. Process validation examples include: product stability testing, QC procedure validations, shipping procedures, product storage validations, product composition testing. Write process validation plan documents, determine acceptance criteria, determine appropriate methods required for testing, data analysis methods and statistical analysis. Complete process validation experiments Collect data, run ELISAs or appropriate test assays, completed data analysis and figures Summarize results and outcomes related to the validations. Compiles digital and written documents related to each experiment. Organize and manage all ongoing process validations and development projects, monitor timelines for long term and short term projects. Work with the Quality Assurance and QC/Engineering team’s to refine process validation plans or results documents. Documents will be ultimately approved by the Lab Director and Quality Assurance team. Coordinate 3 rd party validations or external research studies. New test method validations Manage SOPs associated with 3 rd party testing Update SOPs based on process validations results and procedures. Collaborate with process engineer team to develop new products, protocols, or procedures. Examples: New methods under development include Tangential Flow Filtration of conditioned media, Pressure monitoring techniques for filtration procedures. Ensures work and documentation is completed in compliance with cGMP standards. Ensures data integrity and adherence to Good Documentation Practices (GDP) Supports risk assessments and continuous improvement initiative. Qualifications Candidates should possess strong laboratory skills and hands-on experience with experimental design, execution, and documentation. Candidates should possess expertise in Good Manufacturing Practice (GMP) and familiarity with regulated biologic manufacturing environments. Candidates should possess data analysis skills, including the ability to interpret experimental results and use statistical or computational tools. Relevant qualifications include a bachelor’s or master’s degree in biotechnology or a related scientific field. Strong communication, problem-solving, and documentation skills, along with the ability to work safely and effectively in an on-site laboratory environment, are preferred. #J-18808-Ljbffr ZEO ScientifiX