About this opportunity
BioPhase lists this Sr. Scientist, Analytical Development opportunity in oceanside, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
We are seeking a PhD-level analytical chemistry professional to join our Analytical Development and Quality organization, with level determined by experience (Senior Scientist through Principal Scientist). This role supports the development and commercialization of oligonucleotide-based therapeutics and requires deep technical expertise, strong scientific judgment, and the ability to independently lead complex analytical programs in a regulated environment. The successful candidate will operate with minimal oversight, collaborate cross-functionally, and contribute meaningfully to regulatory strategy and execution.
Key Responsibilities
Serve as the analytical lead for one or more oligonucleotide development programs, providing scientific oversight from early development through clinical and commercial stages
Plan, coordinate, and interpret analytical testing for drug substance intermediates, drug substance, and finished drug product, including release and stability activities
Oversee and manage external testing laboratories, including technical guidance, data review, issue resolution, and performance monitoring
Lead root-cause investigations for analytical or quality-related deviations, implementing scientifically sound corrective actions
Design, develop, and refine analytical methods to support product characterization, control strategy, and lifecycle management
Define and justify drug substance specifications in alignment with CMC strategy and in partnership with Manufacturing, Clinical, Toxicology, and Quality teams
Create and execute method validation, verification, and technology transfer plans consistent with phase-appropriate regulatory expectations
Prepare high-quality technical documentation, including analytical reports and contributions to regulatory submissions (e.g., IND, NDA/BLA sections)
Communicate complex analytical concepts and data clearly in internal reviews and cross-functional scientific forums
Qualifications
PhD in Analytical Chemistry or a closely related scientific discipline (required)
Minimum industry experience:
Senior Scientist: ~2+ years post-doctoral industry experience
Principal Scientist: ~7+ years post-doctoral industry experience
Demonstrated hands-on expertise with chromatographic and mass spectrometric techniques (e.g., LC-MS, HPLC, GC) applied to pharmaceutical drug substances and products
Strong working knowledge of pharmaceutical development workflows and CMC expectations
Direct experience operating within a GMP environment, including data integrity and compliance considerations
Solid understanding of ICH and FDA guidance for analytical method validation and lifecycle management
Proven ability to prioritize and deliver across multiple programs in a fast-paced development setting
Comfortable working independently while also contributing effectively within matrixe
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.