Principal Scientist I, Biologics Analytical Research and Development

About This Role

Planning and executing advanced analytical methods to support biotherapeutic protein characterization, process understanding, and product development is the core of this scientific leadership role. This position involves independently developing innovative approaches, applying state-of-the-art capillary electrophoresis and chromatographic methods, and serving as an analytical lead on development teams. It also includes supervisory responsibilities, such as leading and mentoring scientists and supporting their performance and development.

Responsibilities

• Independently develop state-of-the-art capillary electrophoresis and chromatographic methods to characterize biotherapeutic proteins and their associated variants and impurities
• Generate new scientific proposals and develop innovative approaches to solve difficult analytical challenges
• Represent the Biologics CMC Analytical Research and Development Group as Analytical Lead on CMC development teams and a subject matter expert on cross-functional project teams
• Supervise a team of one or more scientists and be accountable for the effective performance of the team
• Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods
• Provide technical support and oversight for QC testing occurring at internal and external GMP laboratories
• Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, and method qualification/validation protocols
• Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences

Requirements

• Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field
• PhD with 6+ years, MS with 12+ years, or BS with 14+ years of relevant industry experience
• Solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development
• Demonstrated expertise in analytical method development for biologics, with strong hands-on experience in capillary electrophoresis and HPLC
• Experience supporting biologics CMC development, QC method qualification/validation, and method transfer
• Proven ability to interpret complex data, solve technical problems, and propose innovative scientific solutions
• Experience contributing to regulatory submissions, including quality and characterization sections, and responding to health authority questions
• Strong leadership, communication, and collaboration skills, with experience mentoring and supervising scientists
• Capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence