About Us
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 a Senior Scientist to join our nonclinical development team and lead the Bioanalysis function. This is a hands-on, on-site laboratory role, with approximately 60% lab-based work and 40% effort dedicated to data entry, experiment planning, and managing external service providers. 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. 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.
Job Responsibilities
Bioanalytical Method Development and Bioanalysis
- Lead the development, validation, and implementation of LC/MS assays that enable the quantification of lipids, lipid metabolites, glycolipids, and proteins.
- Analyze biological samples utilizing LC/MS assays to support metabolite identification, PK/PD, and biomarker studies.
- Design and execute innovative in vivo studies that utilize LC/MS methodologies.
- Provide guidance on the development, validation, and implementation of all bioanalytical assays used in the nonclinical development team, including ELISA, ddPCR, etc.
- Troubleshoot bioanalytical methods to ensure excellent data quality.
- Manage CROs for assay development, validation, and execution.
- Interpret and report bioanalytical results to support drug discovery and nonclinical development.
- Conduct routine and non-routine bioanalysis.
- Align bioanalytical projects with program timelines.
Collaboration and Communication
- Establish and maintain strong relationships with CROs for timely data delivery.
- Collaborate with internal teams to facilitate planning and execution.
- Prepare documents for technology transfer to CROs.
- Act as a subject matter expert on bioanalysis and method validation, offering guidance to internal and external teams.
- Make detailed observations, analyze data, and communicate results clearly.
- Maintain accurate lab records with good documentation practices.
Laboratory Management and Compliance
- Manage and maintain a safe and organized lab, including equipment and supplies.
- Ensure compliance with SOPs and, when applicable, GLP regulations.
- Maintain excellence in internal and external bioanalytical activities.
Additional Responsibilities
- Write reports, author documents, and prepare SOPs.
- QC study reports and regulatory submissions.
- Mentor or manage junior scientists.
Education
- PhD in Chemistry, Biochemistry, Bioengineering, Pharmacology, or a related field, with 6+ years of relevant biotech industry experience
- Alternatively, a MS degree with 12+ years of relevant biotech industry experience or a BS degree with 15+ years of relevant biotech industry experience
Experience
- Deep experience in bioanalytical method development and validation, with particular emphasis on experience with assays utilizing chromatography and mass spectrometry.
- Technical expertise:
- Hands-on experience with sample preparation, chromatographic separation, and detection by mass spectrometry.
- Expertise in developing, validating, and troubleshooting bioanalytical assays for various biological matrices (e.g., plasma, serum, urine).
- Expertise in utilizing bioanalytical assays for quantification.
- Proficiency with other assay formats, such as ELISA and ddPCR.
- Experience with and knowledge of LC/MS instruments is critical.
- Experience with GLP regulations and understanding of compliance with Good Laboratory Practice (GLP) standards.
- Prior experience running or contributing to GLP toxicology studies is a huge plus.
- Project management skills: Ability to lead and manage bioanalytical projects, including mentoring junior scientists and coordinating with cross-functional teams.
- Strong communication skills: Ability to author and review scientific reports, regulatory documents, protocols, and standard operating procedures (SOPs).
- Collaboration with CROs: Experience in identifying and partnering with contract research organizations (CROs) for bioanalytical assay development using LC-MS.
Additional Skills
- Regulatory knowledge: Familiarity with regulatory guidelines and industry standards for bioanalytical assays.
- Analytical thinking: Strong problem-solving skills and attention to detail.
- Team collaboration: Experience working in multidisciplinary teams and providing technical support.
- Ability to work on several projects and assignments at the same time, with appropriate prioritization.
- A commitment to collaborative leadership, management, teamwork, delegation and foster a professional culture based on trust and mutual respect in a fast-paced environment.
- Scientifically curious, paired with a strong work ethic and grit.
Authorization
- Applicants must have authorization to work in the US
The anticipated salary range for candidates who will work in San Diego, CA is $128,000 to $175,000. 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.