Sr. Scientist, Analytical Development

BioPhase; Oceanside (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A biotech company in California is seeking a PhD-level analytical chemistry professional to lead complex analytical programs for oligonucleotide-based therapeutics. This role requires strong expertise in chromatographic and mass spectrometric techniques along with experience in a GMP environment. The selected candidate will oversee analytical testing and collaborate with cross-functional teams, contributing to regulatory submissions and ensuring compliance with industry standards. Competitive qualifications include 2+ years for a Senior Scientist and 7+ years for a Principal Scientist.

Qualifications

• PhD in Analytical Chemistry or a closely related scientific discipline is required.
• 2+ years post-doctoral industry experience for Senior Scientist role.
• 7+ years post-doctoral industry experience for Principal Scientist role.

Responsibilities

• Lead analytical programs for oligonucleotide development.
• Oversee external testing laboratories and manage analytical testing.
• Create technical documentation for regulatory submissions.

Skills

Chromatographic techniques

Mass spectrometric techniques

Analytical method development

GMP compliance

Regulatory submissions

Education

PhD in Analytical Chemistry or related field

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