Associate Principal Scientist - Analytical Development

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 expertise in biologics, cell and gene therapy, sterile manufacturing, and oral technologies, Catalent partners with pharmaceutical, biotechnology, and consumer health companies worldwide. This position is based in Madison, Wisconsin.

Responsibilities

• 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.

Requirements

• 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.

Skills

Hands-on experience with several of the following:

• 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.

Benefits

• 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.
• Competitive compensation, annual bonus eligibility, comprehensive benefits, and career development opportunities.