Scientist I, Bioanalytical

Enigma Search; South San Francisco (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Enigma Search is seeking a Scientist I, Bioanalytical to oversee the development, validation, and execution of bioanalytical assays for PK/PD across preclinical and clinical programs. The role involves managing CROs, ensuring data integrity, and contributing to regulatory submissions.

The candidate should have a bachelor’s degree in Analytical Chemistry or related field and 6+ years in pharma/biotech bioanalysis, with hands-on LC-MS/MS, ELISA, and MSD experience, operating under GLP/GCLP

Qualifications

• Bachelor's degree in Analytical Chemistry, Biochemistry, or closely related field.
• 6+ years of pharma/biotech bioanalytical oversight experience.
• Hands-on or oversight experience with GLP and GCLP.
• Experience with LC-MS/MS, ELISA, and MSD bioanalytical methods.

Responsibilities

• Oversee development, validation, and execution of bioanalytical assays for PK/PD across preclinical, nonclinical, and clinical programs.
• Manage CROs and external labs, reviewing data to ensure compliance and accuracy.
• Prepare technical summaries of bioanalytical methods for regulatory submissions and filings.
• Coordinate bioanalysis activities across development teams to meet timelines and quality standards.
• Communicate timelines and issues to leadership and cross-functional partners.

Skills

Bioanalysis oversight

LC-MS/MS

ELISA

MSD

GLP/GCLP

Data integrity

Cross-functional collaboration

Regulatory documentation

Education

Bachelor's degree in Analytical Chemistry / related field

Tools

LC-MS/MS instrumentation

ELISA platforms

MSD instruments

Job description

About the job Scientist I, Bioanalytical

Our Client

Our client is an innovative, clinical-stage biopharmaceutical company that leverages a proprietary genetic architecture platform to understand the modifiers of disease. By combining advanced functional genomics, data science, and robust chemical libraries, they translate complex genetic insights into highly targeted, life-changing small molecule therapies. Focused on addressing metabolic, renal, and neurodegenerative disorders with significant unmet needs, they offer a culture driven by deep scientific curiosity, cross‑functional collaboration, and rapid therapeutic translation.

The Opportunity

Are you a detail‑oriented scientist with a passion for driving innovative therapies through preclinical and clinical pipelines?

Our client is seeking a Scientist to join their Non‑Clinical Development team. In this pivotal role, you will provide critical oversight for bioanalytical work across non‑GLP, GLP, and GCLP studies, directly contributing to key drug discovery and clinical milestones.

Reporting directly to the VP of Clinical Pharmacology and Non‑Clinical Development, this position offers incredible cross‑functional visibility, a collaborative culture, and the chance to make a tangible impact on patient lives.

The Impact You’ll Have

• Assay Oversight: Oversee the development, validation, and execution of robust bioanalytical assays for both pharmacokinetics (PK) and pharmacodynamics (PD) across ongoing preclinical, nonclinical, and clinical programs.
• CRO & Vendor Management: Partner with and manage external contract laboratories conducting bioanalysis. Review raw data and batch analyses to ensure compliance, execution, and adherence to acceptance criteria.
• Regulatory Contributions: Author and provide technical, written summaries of bioanalytical methods for upcoming global regulatory submissions.
• Program Coordination: Align and coordinate regulated bioanalysis activities across the broader development portfolio, ensuring strict adherence to project timelines and global regulatory standards.
• Cross‑Functional Collaboration: Provide routine timeline updates to leadership and collaborate directly with internal stakeholders across Research, Regulatory Affairs, Manufacturing, Quality, and Clinical Sciences to swiftly resolve project issues.
• Data Integrity & Quality: Review, investigate, and coordinate the resolution of study queries with CRO personnel to maintain the highest standards of data integrity.

What We’re Looking For

• Education: Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, or a closely related scientific field.
• Experience: 6+ years of relevant industry experience within a pharmaceutical company, biotech, or a CRO with a dedicated focus on bioanalysis oversight.
• Regulatory Rigor: Deep understanding and practical experience working under GLP and GCLP principles and guidelines.
• Technical Proficiency: Hands‑on experience or deep oversight familiarity with key bioanalytical techniques, including LC‑MS/MS, ELISA, and MSD.
• Team‑First Mindset: A proven track record of working effectively within multidisciplinary project teams to drive successful program outcomes.
• Execution Skills: Exceptional attention to detail with the ability to balance and prioritize multiple fast‑moving projects simultaneously.
• Communication: Clear, effective verbal and written communication skills to articulate complex scientific data to diverse technical and non‑technical stakeholders.