Lead Analytical Development & Validation Scientist – Equity

Proclinical; Town of Newark (WI); On-site; USD 150,000 - 160,000; Full time

Benefits offered by this job

Bonus

Equity

Job summary

Proclinical is seeking an Analytical Development and Validation Expert to join a Bay Area on-site team, providing analytical leadership across drug substance and drug product development programmes.

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

Qualifications

• PhD or MSc in Analytical Chemistry or related field.
• Pharmaceutical/biotech Analytical Development experience.
• Expertise in UHPLC/HPLC method development and validation.
• Experience with LC-MS and advanced analytical techniques.
• Background supporting peptides, complex biologics, ADCs or related modalities.
• Experience managing external CDMOs or analytical service providers.
• Experience supporting CMC development across multiple clinical stages.
• Understanding of GMP, quality systems and regulatory expectations.
• Regulatory submission experience is 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.
• Manage analytical testing and development activities at external CDMOs and CROs.
• Review analytical data and provide 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.
• Contribute to continuous improvement and best practice across the organisation.

Skills

UHPLC/HPLC

LC-MS

External CDMOs mgmt

CMC development

GMP/regulatory

Analytical strategy

Analytical method dev

Education

PhD in Analytical Chemistry

MSc in Analytical Chemistry

Tools

LC-MS instruments

Job description

Proclinical is seeking an Analytical Development and Validation Expert to join a Bay Area on-site team, providing analytical leadership across drug substance and drug product development programmes.

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