Principal Scientist I, Biologics Analytical Research and Development

Role Summary

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

The successful candidate will independently develop innovative approaches and apply state-of-the-art capillary electrophoresis and chromatographic methods, serve as an analytical lead on development teams, and contribute to regulatory strategy and scientific innovation. This position also includes supervisory responsibilities, including leading and mentoring one or more scientists and supporting their performance and development.

The role operates within a cross-functional, on-site environment supporting a portfolio that includes multi-specifics, antibodies, ADCs, and novel modalities.

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.

Qualifications & 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.
• Must possess a 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.
• Track record of scientific publications and conference presentations preferred.
• Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.

Preferred Attributes

• 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.

Additional information

This is a full-time, on-site role located in South San Francisco, CA. The position requires daily in-person collaboration across scientific and cross-functional teams. Candidates should expect frequent interaction with both local and global colleagues.

Compensation & Leveling

Compensation and Leveling will be commensurate with experience.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.