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Bioanalytical Cro Jobs in California (NOW HIRING)

5AM Ventures

Analytical Scientist

Emeryville, CA · On-site

$140K - $170K/yr

Lead CRO oversight * Design and manage outsourced bioanalytical studies * Critically review assay development, validation, and sample analysis * Identify deficiencies in methods, data quality, or ...

5AM Ventures

Analytical Scientist

Emeryville, CA · On-site

$140K - $170K/yr

Lead CRO oversight * Design and manage outsourced bioanalytical studies * Critically review assay development, validation, and sample analysis * Identify deficiencies in methods, data quality, or ...

Frontage Laboratories

Scientist

Hayward, CA · On-site

$80K - $110K/yr

Director Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO ... This individual will play a pivotal role in quantitative bioanalysis and the characterization and ...

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Bioanalytical Cro information

What challenges do bioanalytical CRO professionals face, and how can they be addressed?

Professionals working in bioanalytical CROs often encounter challenges such as managing tight project timelines, ensuring regulatory compliance, and adapting to rapidly changing client requirements. Balancing multiple studies simultaneously requires strong organizational skills and effective communication with both internal teams and clients. To address these challenges, it is important to maintain clear documentation, stay updated on industry best practices, and foster a collaborative team environment to ensure high-quality, reproducible results.

What is the difference between Bioanalytical Cro vs Bioanalytical Scientist?

AspectBioanalytical CroBioanalytical Scientist
CredentialsTypically requires a degree in life sciences, pharmacology, or related fields; certifications vary by companyRequires a degree in biology, chemistry, or related fields; advanced degrees preferred
Work EnvironmentContract research organizations, pharmaceutical companies, or biotech firms; project-based workResearch labs, pharmaceutical companies, or academic settings; more independent research
Employer & Industry UsageCommonly hired for clinical trial support and regulatory studiesEngaged in experimental design, data analysis, and method development

While both roles require a background in life sciences, a Bioanalytical Cro primarily manages outsourced projects and client communication, whereas a Bioanalytical Scientist focuses on experimental work and data analysis within a lab setting.

What is a bioanalytical CRO?

Bioanalytical CROs, or Contract Research Organizations, are specialized companies that provide analytical testing services to support pharmaceutical, biotechnology, and medical device development. They focus on analyzing biological samples, such as blood, plasma, or tissue, to quantify drugs, metabolites, or biomarkers. These services are crucial for preclinical and clinical studies, ensuring accurate and reliable data for regulatory submissions. Bioanalytical CROs help companies save time and resources by offering expertise, advanced instrumentation, and compliance with industry regulations.

What skills and qualifications are needed to work in a bioanalytical CRO?

To thrive as a Bioanalytical CRO professional, you need a background in life sciences or chemistry, strong analytical laboratory skills, and often a relevant degree such as a BSc or MSc. Familiarity with technical tools like LC-MS/MS, chromatography software, and compliance with GLP/GCP standards is typically required. Attention to detail, problem-solving abilities, and effective teamwork are crucial soft skills in this field. These skills ensure accurate data generation, regulatory compliance, and successful execution of client-sponsored research projects.
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What job categories do people searching Bioanalytical Cro jobs in California look for? The top searched job categories for Bioanalytical Cro jobs in California are:
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Infographic showing various Bioanalytical Cro job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Analytical Scientist

5AM Ventures

Emeryville, CA • On-site

$140K - $170K/yr

Full-time

Re-posted 7 days ago

Job description

We are seeking an experienced, highly quantitative scientist to lead bioanalytical strategy and quality control across a diverse portfolio of peptide, protein, and small molecule therapeutics. This individual will define analytical approaches, oversee external CROs, and ensure that all data generated are accurate, reproducible, and decision-grade.
This role is ideal for someone who combines deep knowledge of bioanalytical methods with a strong QC mindset and the ability to diagnose and resolve complex analytical challenges across multiple assay platforms.
Qualifications
  • PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field
  • 8-15+ years of relevant experience in biotech, pharma, or CRO environments
  • Demonstrated expertise in bioanalytical method development, validation, and data interpretation within a quality management system (i.e. GLP / GMP)
  • Strong understanding of both:
  • Instrumental analysis as applied to drug substance drug product characterization
  • Experience overseeing and critically evaluating CRO-generated data
  • Working knowledge of GLP / GMP analysis and regulatory expectations (e.g., ICH Q2(R2))
  • Solid grounding in chemical kinetics and interpretation of concentration-time rate data

Preferred Qualifications
  • Experience across multiple molecular modalities (polymers, peptides, proteins, and, small molecules)
  • Background in analytical development or QC for regulated products
  • Experience supporting IND-enabling and early/late stage GMP method validation studies for clinical programs
  • Familiarity with complex or long-acting drug delivery systems

  • Own analytical strategy and method validation
    • Define fit-for-purpose analytical approaches for drug substance / drug product, and mechanistic studies
    • Select appropriate assay platforms (LC, LC-MS, colorimetry, pH, viscosity, osmolarity, endotoxin, bioactivity, and other common USP methods.)
    • Validate methods that define our products critical quality attributes.

  • Lead CRO oversight
    • Design and manage outsourced bioanalytical studies
    • Critically review assay development, validation, and sample analysis
    • Identify deficiencies in methods, data quality, or interpretation and drive resolution

  • Ensure quantitative rigor and data integrity
    • Evaluate instrument calibration models, LLOQ, accuracy/precision, and assay robustness
    • Detect and troubleshoot issues such as matrix effects, instability, adsorption, and assay interference
    • Establish internal standards for data quality across programs

  • Apply QC and regulatory principles
    • Ensure methods and datasets meet GLP and regulatory expectations (e.g., ICH Q2(R2))
    • Contribute to analytical sections of IND-enabling packages and regulatory filings
    • Implement quality systems and documentation standards where needed
  • Support cross-functional decision making
    • Work closely with CMC, pharmacology, and clinical teams to interpret data correctly
    • Provide clear recommendations based on quantitative evidence
    • Write reports that enable cross-functional understanding of methods and results.

  • Operate across modalities
    • Apply consistent analytical thinking across polymers, peptides, biologics, and small molecules
    • Ensure comparability and continuity of data across platforms and studies

$140,000 - $170,000 a year
Final compensation will be based on a candidate's qualifications, experience, and geographic location. Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.
We believe in building balanced teams. We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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