Analytical Development and Validation Expert

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

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 [e-mail]

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