Associate Director, Analytical Development

About Us

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.

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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:
• Analytical techniques, including LCMS, HPLC, UV-Vis spectroscopy, fluorometry, capillary electrophoresis, Karl Fisher, etc.
• 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 . xhyhwjd 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.