Senior Scientist, Analytical Development & QC – High Impact

ProClinical; Newark (CA); On-site; USD 150,000 - 160,000; Full time

Benefits offered by this job

Bonus potential

Equity potential

Job summary

Proclinical is seeking a Sr. Scientist, Analytical Development & Quality Control in the East Bay Area to provide analytical leadership across drug substance and drug product development.

You will lead method development/validation (UHPLC/HPLC, LC-MS), oversee external laboratories, and ensure robust analytical control throughout the product lifecycle. This role offers cross-functional exposure and a competitive package.

Qualifications

• PhD or MSc in Analytical Chemistry or related field.
• Strong pharma/biotech analytical development experience.
• Expertise in UHPLC/HPLC method development and validation.
• Experience with LC-MS and advanced analytical characterization.
• Background supporting peptides, complex biologics, ADCs, proteins or related modalities.
• Demonstrated experience managing external CDMOs or analytical service providers.
• Experience supporting CMC development programmes through multiple clinical stages.
• Understanding of GMP requirements, quality systems and regulatory expectations.
• Regulatory submission experience would be highly advantageous.

Responsibilities

• Lead analytical development activities for drug substance and drug product programmes.
• Develop, optimise and validate analytical methods using modern chromatographic and spectroscopic techniques.
• Design analytical control strategies, specifications and characterisation plans.
• Support stability studies, comparability assessments and impurity characterisation activities.
• Manage analytical testing and development activities at external CDMOs and CROs.
• Review analytical data and provide scientific guidance on investigations, deviations and troubleshooting activities.
• Support regulatory submissions including INDs, IMPDs and marketing applications.
• Collaborate across CMC, Quality and Regulatory functions and drive continuous improvement.

Skills

UHPLC/HPLC

LC-MS

Method development

Regulatory knowledge

GMP compliance

External CDMO management

CMC collaboration

Team leadership

Education

PhD or MSc in Analytical Chemistry

Job description

Proclinical is seeking a Sr. Scientist, Analytical Development & Quality Control in the East Bay Area to provide analytical leadership across drug substance and drug product development.

You will lead method development/validation (UHPLC/HPLC, LC-MS), oversee external laboratories, and ensure robust analytical control throughout the product lifecycle. This role offers cross-functional exposure and a competitive package.