Biologics Analytical Scientist, CMC Lead & Mentor

BioSpace; San Francisco (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

AbbVie Biologics ARD in the Bay Area is seeking a highly skilled analytical scientist to lead development of advanced methods for biotherapeutic protein characterization. The role includes independent method development, cross-functional leadership on CMC development teams, and mentoring junior scientists at an on-site South San Francisco facility.

The successful candidate will drive regulatory strategy, contribute to submissions, and advance QC method qualification and transfer, with

Qualifications

• 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 in biotherapeutic drug development.
• Analytical method development experience for biologics, capillary electrophoresis and HPLC.
• Experience with biologics CMC development, QC method qualification/validation, and method transfer.
• Experience contributing to regulatory submissions and health authority responses.
• Strong leadership, communication, and collaboration skills with mentoring experience.

Responsibilities

• Independently develop state-of-the-art capillary electrophoresis and chromatographic methods for biotherapeutic proteins.
• Generate scientific proposals and innovative analytical approaches to solve challenges.
• Represent Analytical Lead on CMC development teams and cross-functional projects.
• Supervise one or more scientists and manage team performance.
• Develop/qualify/validate and transfer QC release and stability methods; oversee QC testing at GMP labs.
• Plan, author, and review regulatory submission documents and technical reports.
• Engage with the scientific community through publications, posters, and conferences.

Skills

Protein chemistry

Analytical method development

Capillary electrophoresis

HPLC

Regulatory submissions

Data interpretation

Leadership

Mentoring scientists

Scientific publications

Project management

Education

PhD with 6+ years

MS with 12+ years

BS with 14+ years

Job description

AbbVie Biologics ARD in the Bay Area is seeking a highly skilled analytical scientist to lead development of advanced methods for biotherapeutic protein characterization. The role includes independent method development, cross-functional leadership on CMC development teams, and mentoring junior scientists at an on-site South San Francisco facility.

The successful candidate will drive regulatory strategy, contribute to submissions, and advance QC method qualification and transfer, with