Senior Bioanalytical Scientist

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

Job summary

Proclinical Staffing in San Francisco, CA seeks a Senior Bioanalytical Scientist to lead development, qualification, validation, and execution of bioanalytical assays supporting discovery and clinical development programs.

The candidate should have strong hands-on LC-MS/MS experience, expertise in chromatography, and the ability to drive complex projects while collaborating with DMPK, In Vivo Pharmacology, Toxicology, and Clinical Pharmacology teams.

Qualifications

• 5+ years of relevant industry or academic experience
• Strong understanding of chromatography fundamentals
• Hands-on experience operating analytical instrumentation like HPLC and MS

Responsibilities

• Perform hands-on laboratory work to support clinical and non-clinical studies using bioanalytical technologies
• Operate, troubleshoot, and maintain analytical instruments such as HPLC and mass spectrometer
• Review and interpret bioanalytical data and communicate results to cross-functional teams
• Identify trends and variability sources in data
• Develop and evaluate new bioanalytical methods
• Troubleshoot complex assay issues and provide solutions
• Partner with cross-functional scientists to support PK and biomarker analyses
• Contribute to regulatory submissions
• Author/review method development and validation reports and SOPs
• Manage external CROs and testing labs for method transfer and data review

Skills

LC-MS/MS

Chromatography

Data analysis

HPLC

Bioanalysis

Education

MS/PhD in chemistry or related

BS with 10+ years experience

Tools

HPLC

Mass spectrometer

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

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