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Bioanalysis Director Jobs (NOW HIRING)

Prellis Biologics, Inc.

... years direct relevant industry experience); MS with additional years of relevant industry experience also considered. * Hands‑on experience with bioanalytical assay development for biologics ...

AstraZeneca

Head of Regulatory Bioanalysis

Gaithersburg, MD · Hybrid

$162K - $213K/yr

Head of Regulatory Bioanalysis Location: Gaithersburg, Maryland, US Hybrid Working: 3 days per week in the office Bold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ...

AstraZeneca

Head of Regulatory Bioanalysis

Gaithersburg, MD · On-site

$162K - $213K/yr

Head of Regulatory Bioanalysis Location: Gaithersburg, Maryland, US Hybrid Working: 3 days per week in the office Bold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ...

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Bioanalysis Director information

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$122.4K

$186.5K

How much do bioanalysis director jobs pay per year?

As of Sep 12, 2026, the average yearly pay for bioanalysis director in the United States is $122,395.00, according to ZipRecruiter salary data. Most workers in this role earn between $96,500.00 and $141,000.00 per year, depending on experience, location, and employer.

What does a bioanalysis director do?

A Bioanalysis Director oversees the design, implementation, and management of bioanalytical studies, typically within pharmaceutical or biotechnology organizations. They ensure that laboratory operations comply with regulatory standards and that analytical methods for measuring drugs, metabolites, or biomarkers are validated and reliable. Responsibilities also include managing scientific teams, coordinating with other departments, and representing bioanalytical interests in project meetings. Ultimately, they play a key role in ensuring the integrity and quality of data used in drug development.

What are the key skills and qualifications needed to thrive as a bioanalysis director?

A Bioanalysis Director should possess an advanced degree in life sciences, extensive experience in bioanalytical method development, and a strong understanding of regulatory guidelines such as GLP and GCP. Familiarity with analytical instruments like LC-MS/MS, LIMS, and relevant certifications (e.g., ASCP or equivalent) are commonly required. Strong leadership, project management, and communication skills are essential for coordinating teams and collaborating with stakeholders. These competencies ensure scientific rigor, regulatory compliance, and efficient delivery of high-quality data in bioanalytical studies.

What are some common challenges faced by a bioanalysis director when leading cross-functional teams in pharmaceutical research?

A Bioanalysis Director often encounters challenges related to coordinating efforts across multidisciplinary teams, such as scientists, project managers, and regulatory specialists. Ensuring clear communication, alignment on project timelines, and compliance with regulatory standards can be complex, especially in fast-paced environments. Additionally, balancing resource allocation and adapting to shifting scientific priorities requires strong leadership and strategic planning. Overcoming these challenges is key to delivering high-quality analytical data that supports drug development milestones.

What is the difference between Bioanalysis Director vs Bioanalytical Scientist?

AspectBioanalysis DirectorBioanalytical Scientist
Required credentialsAdvanced degree (PhD or MS), leadership experienceBachelor's or Master's in life sciences, specialized training
Work environmentManagement, strategic planning, overseeing teamsLaboratory research, method development, data analysis
Employer usagePharmaceutical, biotech companies, CROsResearch labs, biotech firms, CROs
Search intentLeadership roles, management, strategic oversightTechnical skills, laboratory work, data generation

The Bioanalysis Director typically oversees the entire bioanalytical department, focusing on strategy and management, while the Bioanalytical Scientist conducts hands-on laboratory research and method development. Both roles are essential in the bioanalysis field but differ in responsibilities and seniority.

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Bioanalysis Director jobs near you
Infographic showing various Bioanalysis Director job openings in the United States as of September 2026, with employment types broken down into 2% As Needed, 84% Full Time, 12% Part Time, 1% Temporary, and 1% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $122,395 per year, or $58.8 per hour.

Associate Director, Bioanalytics

San Francisco, CA • On-site

Latigo Biotherapeutics
See more jobs at Latigo Biotherapeuticsexternal

$200K - $220K/yr

Full-time

Posted 10 days ago

Key responsibilities

  • Lead bioanalytical activities supporting discovery, nonclinical, and clinical development programs.

  • Manage CROs and laboratory service providers to ensure timely delivery of high-quality bioanalytical data.

  • Ensure bioanalytical activities comply with regulatory standards and support regulatory submissions.

Job description

Job Title: Associate Director, Bioanalytics
Location: Thousand Oaks, CA or San Francisco, CA
Reporting to: VP, Translational Science
Company Description:
Latigo Biotherapeutics, Inc. is an early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team and an experiencedBoard of Directors. At Latigo, we value science, patient-focus, and innovation.
Position Description:
Latigo is seeking an experienced and highly motivated Associate Director, Bioanalytics to lead bioanalytical activities supporting discovery, nonclinical, and clinical development programs. This individual will provide strategic and operational leadership for bioanalytical assay development, validation, and sample analysis activities conducted through external CRO partners and internal collaborators.
The successful candidate will serve as the bioanalytical subject matter expert across multiple programs and will work closely with Clinical Pharmacology, Biomarkers, Toxicology, DMPK, Clinical Operations, Regulatory Affairs, and Quality teams to ensure delivery of high-quality bioanalytical data that support key development decisions and regulatory submissions.
The ideal candidate will possess deep expertise in ligand binding assays, LC-MS/MS methodologies, biomarker assay platforms, and regulatory expectations for bioanalytical method validation. Experience supporting both small molecule and biologic drug development programs is desirable.
Key Responsibilities:
Bioanalytical Strategy & Leadership
  • Develop and execute bioanalytical strategies to support discovery, nonclinical, and clinical development programs.
  • Serve as the bioanalytical lead on cross-functional project teams.
  • Contribute to overall development strategy, timeline planning, and risk assessment activities.

CRO and Vendor Management
  • Identify, select, and manage CROs and laboratory service providers.
  • Oversee bioanalytical method development, qualification, validation, transfer, and sample analysis activities.
  • Review study plans, protocols, validation reports, and analytical data packages.
  • Ensure timely delivery of high-quality data and compliance with project timelines and budgets.

Regulatory & Quality Compliance
  • Ensure bioanalytical activities are conducted in accordance with GLP, GCP, and applicable regulatory guidance.
  • Author and review bioanalytical sections of regulatory submissions, including INDs, CTAs, briefing packages, IBs, and NDAs.
  • Support regulatory agency interactions and responses related to bioanalytical methodologies and data.
  • Collaborate with Quality Assurance to oversee inspections, audits, deviations, investigations, and CAPAs.

Data Review & Interpretation
  • Collaborate with Clinical Pharmacology, DMPK, and Biomarker teams to integrate bioanalytical findings into study and program assessments.
  • Present results and recommendations to project teams, senior leadership, and external stakeholders.

Team Collaboration & Development
  • Establish strong partnerships across Research, Development, Clinical, Regulatory, and CMC functions.
  • Mentor junior scientists and contribute to the growth of bioanalytical capabilities within the organization.
  • Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.

Qualifications
Education
  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Pharmacology, or a related scientific discipline with 8+ years of relevant industry experience; or
  • M.S. degree with 12+ years of relevant industry experience; or
  • B.S. degree with 15+ years of relevant industry experience.

Experience
  • Significant bioanalytical experience supporting drug discovery and development for small molecule programs in the biotechnology or pharmaceutical industry.
  • Demonstrated expertise managing outsourced bioanalytical activities.
  • Extensive experience with LC-MS/MS methodologies for small molecule quantitation.
  • Strong understanding of FDA, EMA, and ICH bioanalytical method validation guidance.
  • Experience supporting regulatory filings and interactions.
  • Proven ability to influence cross-functional teams and manage multiple programs simultaneously.

Preferred Qualifications
  • Experience supporting Phase 1 through Phase 3 clinical studies.
  • Experience with pain, neuroscience, ion channel, or CNS drug development programs.

Core Competencies
  • Strategic thinking and scientific leadership
  • Strong project management and organizational skills
  • Excellent written and verbal communication abilities
  • Collaborative and team-oriented mindset
  • Sound judgment and decision-making
  • Ability to thrive in a fast-paced, entrepreneurial biotech environment

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