Associate Principal Scientist - Analytical Development

Associate Principal Scientist, Analytical Development Madison, Wisconsin, United States Catalent Pharma Solutions is a leading global contract development and manufacturing organization (CDMO) dedicated to developing, manufacturing, and supplying products that help people live better and healthier lives. Through our expertise in biologics, cell and gene therapy, sterile manufacturing, and oral technologies, we partner with pharmaceutical, biotechnology, and consumer health companies worldwide. Catalent is seeking an Associate Principal Scientist, Analytical Development to join our growing Analytical Development team in Madison, WI. This technical leadership role will serve as a subject matter expert supporting analytical method development, characterization, qualification, validation, and transfer activities for a diverse portfolio of biologics and advanced therapeutics. The successful candidate will provide scientific leadership across complex client programs while driving analytical strategy, mentoring junior scientists, and contributing to the expansion of technical capabilities within the organization. The Role Serve as a scientific leader and analytical subject matter expert for biologics development programs. Lead analytical method development, optimization, qualification, transfer, and validation activities. Design and execute studies using Analytical Quality by Design (AQbD) principles and Design of Experiments (DoE). Support characterization and release testing strategies for biologics, recombinant proteins, monoclonal antibodies, nucleic acids, and emerging modalities. Interpret complex analytical data and provide recommendations to internal teams and external clients. Author and review technical reports, protocols, SOPs, deviations, and scientific documentation. Provide technical oversight across multiple client projects while ensuring timelines and deliverables are achieved. Mentor scientists and contribute to the technical growth of the Analytical Development organization. Support regulatory submissions, client audits, and agency interactions as needed. Evaluate and implement new analytical technologies to enhance departmental capabilities. Candidate Education & Experience PhD in Biochemistry, Analytical Chemistry, Molecular Biology, Biotechnology, or related scientific discipline with 6+ years of relevant experience; OR Master's degree with 10+ years of relevant industry experience; OR Bachelor's degree with 12+ years of relevant industry experience. Required Technical Expertise HPLC/UPLC (SEC, RP, IEX, HIC)

LC-MS

CE-SDS

cIEF/iCE

SDS-PAGE

ELISA

Western Blot Potency and binding assays qPCR and dPCR Nucleic acid characterization techniques Method qualification, validation, and transfer Preferred Qualifications Experience supporting biologics, gene therapy, nucleic acid-based therapeutics, viral vectors, or lipid nanoparticle programs. Strong understanding of cGMP environments and ICH guidance. Experience within a CDMO organization. Proven ability to lead cross-functional technical teams. Experience supporting regulatory submissions and agency interactions. Working knowledge of statistical tools such as JMP or Design-Expert. Why You Should Join Catalent Work on cutting-edge biologics and advanced therapeutic programs. Collaborate with industry-leading scientists and technical experts. Influence analytical strategy across a diverse client portfolio. Grow your career within a global organization focused on innovation and patient impact. Benefits Competitive compensation, annual bonus eligibility, comprehensive benefits, and career development opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. #J-18808-Ljbffr Catalent Pharma Solutions