Senior Scientist - Analytical Development & QC Impact

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

Job summary

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

You will design strategies, oversee external laboratories and ensure robust analytical control throughout the product lifecycle, working across CMC, Regulatory, Quality and Manufacturing in a fast-moving biotech setting.

Qualifications

• PhD or MSc in Analytical Chemistry or related discipline.
• Strong pharma/biotech experience within Analytical Development.
• Expertise in UHPLC/HPLC method development and validation.
• Experience with LC-MS and advanced analytical characterisation techniques.
• Background supporting peptides, complex biologics, ADCs, proteins or related modalities.
• Experience managing external CDMOs or analytical service providers.
• Experience supporting CMC development through multiple clinical stages.
• Understanding of GMP, 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.
• Support regulatory submissions including INDs, IMPDs and marketing applications.
• Collaborate with cross-functional teams across CMC, Quality and Regulatory functions.
• Contribute to continuous improvement and best practice across the organisation.

Skills

UHPLC/HPLC method development

LC-MS

External CDMO management

Analytical Development leadership

GMP & regulatory knowledge

Biologics/peptides/ADCs

IND/CMC submissions

Analytical strategy

Education

PhD in Analytical Chemistry

MSc in Analytical Chemistry

Tools

UHPLC/HPLC

LC-MS

Job description

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

You will design strategies, oversee external laboratories and ensure robust analytical control throughout the product lifecycle, working across CMC, Regulatory, Quality and Manufacturing in a fast-moving biotech setting.