About this opportunity
Seawolf Therapeutics, Inc. lists this Associate Director, Analytical Development opportunity in san diego, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Seawolf Therapeutics is a venture-backed company based in San Diego, CA. We are an innovative and collaborative team developing DNA-based medicines that will be first-in-class and best-in-class long-acting therapeutics for patients living with unmet medical needs. Come join our team and be an agent of change.
Position Summary
Seawolf Therapeutics is seeking an experienced Associate Director, Analytical Development to lead the analytical function as a key member of the delivery Technology team, with end-to-end accountability for the analytical activities required to enable discovery research, platform development, and CMC readiness. This is an on-site role that pairs technical leadership with continued hands‑on engagement, with approximately 30% lab work and 70% strategy, experimental design, data interpretation, people leadership, and cross‑functional analytical support. The individual will build and lead the team responsible for developing, optimizing, qualifying, and trouble‑shooting the analytical methodologies required for the characterization of a nanoparticulate delivery system and the nucleic acid cargo, and will own the analytical control strategy as programs advance from discovery through IND‑enabling studies and into early clinical development. This role requires someone who thrives in a fast‑paced, collaborative environment, can prioritize tasks based on strategic goals and timelines, and communicates effectively between cross‑functional teams.
Key Responsibilities
Technical Oversight
Serve as the company’s analytical subject matter expert across all analytical methodologies, including LCMS, RP-HPLC, SEC, SAX, CGE, spectroscopy, and fluorometry
Own the analytical control strategy, ensuring accurate quantification of critical components of the final LNP drug product (e.g., ligand, lipid, DNA, and RNA) and quality control of drug substance and drug product, including definition of critical quality attributes (CQAs) and phase‑appropriate specifications
Plan, coordinate, delegate, and when needed directly perform sample analysis in support of company objectives
Method Development
Lead the development of the internal analytical capabilities that support all R&D activity, from early discovery screening through IND‑enabling characterization
Troubleshoot complex analytical challenges and identify bottlenecks in the analytical workflows to improve turnaround time and efficiency
Ensure all methods are performed in a phase‑appropriate manner, leading the pre‑qualification, qualification, and validation efforts when necessary
Management
Recruit, train, and lead a team of analytical scientists
Set priorities, own timelines, and coordinate the team’s activities both internally and across departments in line with program objectives
CMC and Regulatory
Author, review, and approve the analytical sections of regulatory and support responses to health authority information requests
Establish impurity and degradation control strategies covering process‑ and product‑related impurities, residual solvents, and elemental impurities
Partner with QA and external GMP QC laboratories on method transfer, OOS/OOT investigations, and audit and inspection readiness
Define and justify phase‑appropriate specifications for drug substance and drug product
Documentation
Maintain high standards for scientific integrity and accountability
Ensure accurate and thorough documentation of experimental procedures, data, and method development activities
Review and approve data generated by junior team members
Contribute to technical reports, SOPs, and the analytical sections of regulatory filings Cross-
Cross‑functional Collaboration
Collaborate with a team of scientists to creatively solve problems and drive innovation
Communicate across departments and support project teams
Lead analytical technology transfer to manufacturing or external partners
Adapt to evolving project priorities in a fast‑paced, data‑driven environment
Requirements
PhD in Analytical Chemistry or related discipline with 9+ years of relevant industry experience, or BS/MS with 15‑18+ years of relevant industry experience
Demonstrated proficiency in mass spectrometry, including LC‑MS/MS method development and data interpretation for protein identification, quantitation, and impurity profiling, as well as for lipid identification, quantitation, and impurity profiling. A detailed understanding of tryptic digests and peptide mapping for protein analysis is strongly preferred. Hands‑on experience with high‑resolution platforms (Q‑TOF or Orbitrap) is strongly preferred.
Prior hands‑on experience with the following:
Prior experience with the characterization and quantification of nucleic acid‑based therapeutics
Prior experience with nanoparticulate delivery systems is an advantage
Prior experience with RT‑qPCR and ddPCR is an advantage
Able to conduct self‑directed research and thrive in a dynamic and fast‑paced entrepreneurial setting with a diverse team of coworkers
Experience with regulatory CMC for the development stage of drug product is an advantage
Exceptional problem‑solving skills, outstanding interpersonal skills, excellent written and oral communication skills, creativity, enthusiasm, reliability, and attention to details
Scientifically curious, paired with a strong work ethic and grit
Open‑minded, respectful of others, and a strong proponent of an inclusive culture
Embraces the lean start‑up mentality and is willing to wear multiple hats
Authorization
Applicants must have authorization to work in the US
The anticipated salary range for candidates who will work in San Diego, CA is $170,000 to $195,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
Seawolf provides competitive salaries and an excellent benefits package including medical, dental, vision, life insurance, 401K, stock options and bonus.
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.