Principal Scientist I, Biologics Analytical Research and Development

About the role

The Biologics CMC Analytical Research and Development Group is seeking a highly skilled and motivated analytical scientist to join our team. This role provides scientific leadership in the development of advanced analytical methods to support biotherapeutic protein characterization, process understanding, and product 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

• Minimum of 6+ years of relevant industry experience with a degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
• Strong understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development.
• 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.

Qualifications

• Deep understanding of biologics analytics, impurity profiling, and protein characterization.
• Ability to work effectively across functions and influence scientific and technical decisions.
• Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
• Commitment to scientific excellence, quality, and continuous improvement.