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.

The Candidate Education & Experience

PhD in Biochemistry, Analytical Chemistry, Molecular Biology, Biotechnology, or related scientific discipline with 6+ years of relevant experience; ORMaster's degree with 10+ years of relevant industry experience; OR Bachelor's degree with 12+ years of relevant industry experience.

Required Technical Expertise Hands-on experience with several of the following:

HPLC/UPLC (SEC, RP, IEX, HIC)
LC-MSCE-SDS, cIEF/iCESDS-PAGEELISAWestern Blot Potency and binding assaysqPCR and dPCRNucleic 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 with in 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.

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

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the…