About this opportunity
Proclinical lists this Analytical Development and Validation Expert opportunity in town of newark, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Analytical Development and Validation Expert
Bay Area - On-site
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 working alongside a clinical-stage biotechnology company developing innovative medicines for serious diseases with significant unmet medical need. With multiple assets advancing through late-stage clinical development and strategic partnerships with major global pharmaceutical companies, the organisation is entering an exciting period of growth and portfolio expansion.
As part of a highly collaborative CMC organisation, the company is seeking an Analytical Development & Validation Expert to provide analytical leadership across drug substance and drug product development programmes.
Primary Responsibilities:
This is an excellent opportunity for an experienced analytical scientist who enjoys combining hands-on scientific expertise with strategic programme leadership.
You will act as a key analytical subject matter expert, working across development stages to design analytical strategies, oversee external laboratories and ensure robust analytical control throughout the product lifecycle.
The role offers significant visibility across CMC, Regulatory Affairs, Quality, Manufacturing and Technical Operations teams, making it ideal for someone looking to broaden their impact within a fast-moving biotechnology environment.
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 characterisation 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 programmes through multiple clinical stages
Understanding of GMP requirements, quality systems and regulatory expectations
Regulatory submission experience would be highly advantageous
The Analytical Development and Validation Expert's responsibilities will be:
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 closely with cross-functional teams across CMC, Quality and Regulatory functions
Contribute to continuous improvement initiatives and scientific best practice across the organisation
Compensation:
$150,000 to $160,000 per annum.
Why Join?
Opportunity to work on innovative peptide therapeutics approaching key clinical and commercial milestones
Broad ownership and visibility across multiple development programmes
Exposure to both scientific and strategic CMC activities
Collaborative biotech culture with direct access to senior leadership
Strong compensation package including bonus and equity potential
Opportunity to contribute to medicines with the potential to transform patient outcomes
If you are having difficulty in applying or if you have any questions, please contact Neil Walton at
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.