Sr. Scientist, Analytical Development and Quality Control

Description

Sr. Scientist, Analytical Development and Quality Control – Permanent – East Bay Area

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 a Senior Scientist, Analytical Development & Quality Control 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 disciplineStrong pharmaceutical or biotechnology industry experience within Analytical DevelopmentExpertise in UHPLC/HPLC method development and validationExperience with LC–MS and advanced analytical characterisation techniquesBackground supporting peptides, complex biologics, ADCs, proteins or related therapeutic modalitiesDemonstrated experience managing external CDMOs or analytical service providersExperience supporting CMC development programmes through multiple clinical stagesUnderstanding of GMP requirements, quality systems and regulatory expectationsRegulatory submission experience would be highly advantageous

The Sr. Scientist's responsibilities will be:

Lead analytical development activities for drug substance and drug product programmesDevelop, optimise and validate analytical methods using modern chromatographic and spectroscopic techniquesDesign analytical control strategies, specifications and characterisation plansSupport stability studies, comparability assessments and impurity characterisation activitiesManage analytical testing and development activities at external CDMOs and CROsReview analytical data and provide scientific guidance on investigations, deviations and troubleshooting activitiesSupport regulatory submissions including INDs, IMPDs and marketing applicationsCollaborate closely with cross–functional teams across CMC, Quality and Regulatory functionsContribute 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 milestonesBroad ownership and visibility across multiple development programmesExposure to both scientific and strategic CMC activitiesCollaborative biotech culture with direct access to senior leadershipStrong compensation package including bonus and equity potentialOpportunity 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 (url removed)

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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Ad ID: 5418854302