Senior Bioanalytical Scientist

Proclinical Group; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Proclinical Group seeks a Senior Bioanalytical Scientist in San Francisco to lead the development and validation of bioanalytical assays across discovery and clinical programs. The role emphasizes hands-on LC-MS/MS work, data interpretation, and cross-functional collaboration with DMPK, In Vivo, and Clinical Pharmacology teams.

The ideal candidate has 5+ years in industry or academia (or 10+ years with BS), strong chromatography expertise, and proven instrument maintenance skills in HPLC and MS,

Qualifications

• MS/PhD in chemistry, analytical chemistry, biochemistry, bioengineering, or related fields with 5+ years of experience or BS with 10+ years.
• Strong understanding of chromatography and analytical separations.
• Experience operating and maintaining analytical instrumentation including HPLC, MS, spectrophotometers and data software.

Responsibilities

• Lead hands-on bioanalytical assay development and data interpretation for clinical and non-clinical studies.
• Operate and maintain analytical instruments such as HPLC and mass spectrometers.
• Review and interpret bioanalytical data and regulatory documentation.
• Identify trends and sources of variability in assay results.
• Develop and evaluate new bioanalytical methods for development programs.
• Troubleshoot complex assay issues and propose scientifically sound solutions.
• Collaborate with DMPK, Biology, Toxicology, and Clinical Pharmacology for PK and biomarker analyses.
• Contribute to departmental strategy, tech development, regulatory guidance, and submissions.

Skills

Bioanalytical expertise

LC-MS/MS experience

Analytical instrumentation

Education

MS/PhD in chemistry/related fields

Tools

HPLC

Mass spectrometer

Spectrophotometers

Data analysis software

Job description

Senior Bioanalytical Scientist - Permanent - San Francisco, CA

Lead the science behind tomorrow's medicines by advancing bioanalytical strategies from discovery through clinical development.

We are seeking an experienced and highly motivated Senior Bioanalytical Scientist to lead the development, optimization, qualification, validation, and execution of bioanalytical assays supporting discovery and clinical development programs.

Primary Responsibilities:

The successful candidate will serve as a scientific and technical expert in bioanalytical strategy and assay development, work collaboratively with DMPK, In Vivo Pharmacology, Toxicology, Clinical Pharmacology, and other cross-functional teams to generate high-quality bioanalytical data that inform critical drug-development decisions. The ideal candidate has strong hands-on expertise with LC-MS/MS or other quantitative bioanalytical technologies and a demonstrated ability to independently drive complex projects.

Skills & Requirements:

• MS/PhD in chemistry, analytical chemistry, biochemistry, bioengineering, or related fields with 5+ years of relevant industry or academic experience or BS with 10+ years of experience
• Strong understanding and experience with the fundamentals of chromatography and analytical separations
• Experience operating and maintaining analytical instrumentation, including HPLC, mass spectrometer, spectrophotometers, and data analysis software

The Senior Bioanalytical Scientist's responsibilities will be:

• Perform hands-on laboratory work to support clinical and non-clinical studies such as sample analysis and data interpretation using appropriate bioanalytical technologies and instrumentation
• Operate, troubleshoot, and maintain analytical instruments such as HPLC, mass spectrometer, and other lab equipment
• Review and interpret bioanalytical data, reports, protocols, validation plans, and technical documentation and effectively communicate to other departments or external organizations
• Identify trends, anomalies, and potential sources of variability
• Develop, improve, and evaluate new bioanalytical methods and assays to implement to support pharmaceutical development programs
• Troubleshoot complex assay and sample-analysis issues and develop scientifically sound solutions
• Partner with DMPK, Biology, Toxicology, and Clinical Pharmacology scientists to support PK, toxicokinetic, exposure-response, and biomarker analyses and effectively communicate results to the cross-functional project teams
• Contribute to departmental strategy, technology development, and process improvement initiatives by staying current with advances in bioanalytical technologies, regulatory guidance, and industry practices
• Contribute to regulatory submissions
• Author and/or review bioanalytical method development reports, validation reports, study reports, protocols, SOPs, and technical reports
• Manage external CROs and testing laboratories, including method transfer, assay execution, data review, and issue resolution

Compensation:

• $120 000 - $150 000 Per Annum