Senior Scientist / Senior Scientistess

Senior Scientist, Analytical Development and Quality Control - Permanent - East Bay Area

Are you ready to play a pivotal role in bringing innovative therapies to patients while shaping analytical strategy across a growing late-stage biotech pipeline? Proclinical is collaborating with a clinical-stage biotechnology company dedicated to developing groundbreaking medicines for serious diseases with significant unmet medical needs. With multiple assets advancing through late-stage clinical development and strategic partnerships with major global pharmaceutical companies, the organization is entering an exciting period of growth and portfolio expansion.

Position Overview

As part of a highly collaborative CMC organization, we are seeking a Senior Scientist in Analytical Development & Quality Control to provide analytical leadership across drug substance and drug product development programs. This role presents an excellent opportunity for an experienced analytical scientist who enjoys combining hands-on scientific expertise with strategic program leadership.

Primary Responsibilities

• Lead analytical development activities for drug substance and drug product programs.
• Develop, optimize, and validate analytical methods using modern chromatographic and spectroscopic techniques.
• Design analytical control strategies, specifications, and characterization plans.
• Support stability studies, comparability assessments, and impurity characterization 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 and IMPDs.
• Collaborate closely with cross-functional teams across CMC, Quality, and Regulatory functions.
• Contribute to continuous improvement initiatives and scientific best practices across the organization.

Skills & Requirements

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

Compensation

Annual compensation ranges from $150,000 to $160,000.

Why Join Us?

• Opportunity to work on innovative peptide therapeutics approaching key clinical and commercial milestones.
• Broad ownership and visibility across multiple development programs.
• Exposure to both scientific and strategic CMC activities.
• Collaborative biotech culture with direct access to senior leadership.
• Strong compensation package, including bonuses and equity potential.
• Chance to contribute to medicines with the potential to transform patient outcomes.

If you are interested in applying to this exciting opportunity, please Apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional individuals and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.