Associate Director, Bioanalysis/Translational Assay Development

Associate Director, Bioanalysis/Translational Assay Development Associate Director, Bioanalysis/Translational Assay Development Seawolf Therapeutics is a Series A 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. Overview of Role Seawolf Therapeutics is seeking an Associate Director to join our nonclinical development team and lead multiple drug metabolism and bioanalytical functions in discovery and development staged programs. This individual will be responsible for overseeing the development, validation, and implementation of several bioanalytical assays. A key point of focus will be to develop LC/MS-based assays, including but not limited to, detection and quantification of lipids, glycolipids, and proteins. The ideal candidate will have a strong foundation in the bioanalysis of nucleic acids and biologics in both regulated and non-regulated environments as well. Additional experience with building ADA and potency assays for large biologics is a plus. This role additionally requires collaboration with internal functional team leaders to compile critical information for developing bioanalytical assays, as well as building and maintaining relationships with external contract laboratories to operationalize technology transfer, assay development, and method validation. An ideal candidate is a collaborative scientific leader with the ability to drive and facilitate complex technical discussions, mentor junior scientists, and contribute to assay development through both strategic insight and hands-on expertise. Job Responsibilities Assay Development & Bioanalysis Design and develop translational assays in collaboration with the project teams. Create custom assays (e.g., LC/MS, ELISA, MSD, qPCR, ddPCR) for PK, PD, biodistribution, and immunogenicity. Plan and execute validation of critical PK assays for GLP sample analysis to support regulatory filings. Lead ADA and potency assay development and qualification for biologics. Perform sample analysis for non-regulated and regulated preclinical studies. Troubleshoot internal and external bioanalytical methods to ensure data quality. Provide budget projections and manage contracts for studies. Stay current with industry practices and regulatory guidance. Collaborate with internal teams to align experimental designs and timelines with project goals. Communicate results and make recommendations to guide strategic discussions. Support CRO selection and manage assay transfer for regulated studies. Ensure CRO deliverables are met and manage priorities for ongoing activities at CROs. Documentation & Reporting Prepare documents for method transfer to CROs. Contribute to study plans, validation reports, protocols, and regulatory documents. QC study reports and regulatory submissions as needed. Support research reports and presentations for internal and external audiences. Data & Knowledge Management Analyze data from internal studies, CROs, and literature to guide decisions. Interpret PK, pharmacology, and toxicology data to inform program strategy. Contribute to data curation and knowledge infrastructure. Additional Responsibilities Leads scientific discussions across the organization for data-driven decisions. Mentor or manage junior scientists. Education PhD in Chemistry, Biochemistry, Bioengineering, Pharmacology, or a related field, with 10+ years of relevant biotech industry experience Alternatively, a MS degree with 15+ years of relevant biotech industry experience or a BS degree with 20+ years of relevant biotech industry experience Experience Technical & Scientific Expertise Gained extensive hands-on experience in protein binding, in vitro and in vivo metabolism studies, tissue distribution, as well as PK modeling/simulation software to support pharmacokinetic and metabolic profiling. Developed and validated a wide range of bioanalytical assays, including LC/MS, ELISA, MSD, ADA, potency assays, and nucleic acid quantification using qPCR/ddPCR or other methods. Regulatory & Operational Knowledge Demonstrated deep knowledge of GLP regulations and ensured compliance in all aspects of bioanalytical method development and validation. Contributed to and/or led GLP toxicology studies and partnered with CROs for assay development and execution. Authored and reviewed scientific reports, regulatory submissions, protocols, and SOPs, ensuring clarity and regulatory alignment. Core Competencies Applied strong analytical thinking and problem-solving skills to troubleshoot complex assay issues and interpret experimental outcomes. Recognized and addressed anomalous results, ensuring data integrity and scientific rigor. Delivered clear and compelling presentations of complex scientific data to cross-functional teams and senior leadership. Managed multiple concurrent projects with a high degree of accuracy, efficiency, and prioritization. Leadership Successfully led cross-functional scientific teams and managed complex bioanalytical projects. Effectively planned and coordinated project work across departmental, functional, and external stakeholders, ensuring alignment with timelines and deliverables in a fast-paced, dynamic setting. Fostered a respectful team environment, emphasizing scientific curiosity, grit, and a strong work ethic. Championed mentorship and effective delegation, supported the development of junior scientists, and promoted a culture of continuous learning and innovation. Authorization Applicants must have authorization to work in the US The anticipated salary range for candidates who will work in San Diego, CA is $150,000 - $190,000 . 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. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Science Referrals increase your chances of interviewing at Seawolf Therapeutics, Inc. by 2x Get notified about new Associate Director jobs in San Diego, CA . Director/Senior Director, Clinical Scientist Senior Project Manager, Customer Experience San Diego, CA $81,000.00-$107,500.00 9 hours ago Senior Manager, Donor Services & Insights Senior Manager, Health Care Transformation Construction Manager/Senior Construction Manager Sr. Manager/Associate Director of Supply Chain - Biotech San Diego, CA $86,500.00-$129,500.00 19 hours ago Solana Beach, CA $100,000.00-$120,000.00 2 days ago Full Time - Human Resources Generalist, Snapdragon Stadium Associate Director of Development, Office of Housing Administration (Administrator I) Associate Director, Analytical Development Academic Advisor (Student Services Professional II) Associate Director, Clinical Quality Assurance Senior Director, Business Operations - Chief of Staff Senior/Executive Director, Program Leadership and Regulatory Operations Associate Director of Regulatory Affairs Senior Manager of STAR Events and Communication San Diego, CA $150,500.00-$220,000.00 23 hours ago Executive Director/Vice President, Clinical Operations San Diego Metropolitan Area $200,000.00-$260,000.00 2 days ago Associate Director of Regulatory Affairs San Diego Metropolitan Area $160,264.00-$200,330.00 2 months ago San Diego, CA $60,858.23-$106,311.29 5 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr