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Bioanalysis Director Jobs in California (NOW HIRING)

General Proximity

Head of DMPK

San Francisco, CA · On-site

... direct modulation by the drug, the classical approach). Historically, the development of ... Bioanalytical Sciences * Own or oversee bioanalytical strategy for the portfolio, including LC-MS ...

Evommune, Inc.

Director, DMPK

Palo Alto, CA · On-site

The Director, DMPK will serve as the DMPK program lead, responsible for establishing and executing ... Partner closely with Medicinal Chemistry, Pharmacology, Toxicology, CMC, Bioanalytical, and ...

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Bioanalysis Director information

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 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.

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 are the key skills and qualifications needed to thrive as a Bioanalysis Director, and why are they important?

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 popular job titles related to Bioanalysis Director jobs in California? For Bioanalysis Director jobs in California, the most frequently searched job titles are:
What job categories do people searching Bioanalysis Director jobs in California look for? The top searched job categories for Bioanalysis Director jobs in California are:
What cities in California are hiring for Bioanalysis Director jobs? Cities in California with the most Bioanalysis Director job openings:
Bioanalysis Director jobs near you
Associate Director, Bioanalytical Sciences

Associate Director, Bioanalytical Sciences

Travere Therapeutics

San Diego, CA • On-site

Full-time

Medical, Life, Retirement, PTO

Posted 7 hours ago

Job description

Department:
106200 Research & Non-Clinical Dev
Location:
San Diego, USA- Remote
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
Travere Therapeutics is seeking an experienced and strategic scientist to join our Research and Nonclinical Development organization as Associate Director, Bioanalytical Sciences. This individual will provide scientific, operational, and cross-functional leadership for bioanalytical activities supporting nonclinical and clinical development programs across the portfolio.
The successful candidate will bring expertise in regulated bioanalysis supporting both small molecule and biologic development programs, including ligand-binding assay (LBA) platforms for biomarker, diagnostic, target engagement, pharmacodynamic, and immunogenicity applications, as well as LC-MS/MS methodologies supporting pharmacokinetic and metabolite analyses. The individual will work closely with DMPK, Translational Sciences, Clinical Pharmacology, Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Quality, and external partners to develop and execute bioanalytical strategies that support global clinical development, regulatory submissions, and data-driven decision making.
This role serves as the functional bioanalytical lead on multidisciplinary program teams and is responsible for end-to-end oversight of bioanalytical activities spanning assay strategy, CRO oversight, sample lifecycle management, data review, and regulatory support.
Responsibilities:
  • Serve as the functional lead for Bioanalytical Sciences on cross-functional development teams.
  • Develop and execute phase-appropriate bioanalytical strategies aligned with program objectives, timelines, and regulatory requirements.
  • Provide strategic oversight of bioanalytical methods supporting PK, TK, biomarker, diagnostic, target engagement, pharmacodynamic, and immunogenicity analyses.
  • Lead development, qualification, validation, transfer, and implementation of LBA and LC-MS/MS methods through external partners.
  • Collaborate with Translational Sciences and Clinical Development teams to implement biomarker strategies supporting disease monitoring, patient stratification, target engagement, and pharmacodynamic assessment.
  • Partner with Clinical Development, Clinical Operations, Biometrics, Data Management, and laboratory vendors to support protocol development, laboratory manuals, sample handling procedures, and bioanalytical operational plans.
  • Oversee collection, processing, shipment, reconciliation, analysis, and reporting of bioanalytical samples across global clinical studies.
  • Ensure timely transfer, review, reconciliation, and delivery of bioanalytical data to internal stakeholders, including Biometrics and Regulatory Affairs.
  • Develop and maintain strategic relationships with CROs, central laboratories, and specialty testing laboratories.
  • Monitor vendor performance and resolve scientific, operational, and quality-related issues.
  • Support global regulatory submissions and ensure bioanalytical activities comply with applicable FDA, EMA, and other international regulatory requirements.
  • Partner with Quality group on GCLP/GLP vendor audits and regulatory pre-approval inspections.
  • Review bioanalytical reports and data packages to ensure scientific integrity, regulatory readiness, and data quality.
  • Additional duties assigned as needed.

Education/Experience Requirements:
  • PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Pharmacology, or a related scientific discipline. Equivalent combination of education and applicable job experience may be considered.
  • Minimum 4 years of relevant experience in the biopharmaceutical industry.
  • Significant experience in regulated bioanalysis utilizing LBA and/or LC-MS/MS platforms supporting clinical and nonclinical development.
  • Demonstrated experience overseeing assay development, validation, and sample analysis through CRO partners.
  • Experience supporting global clinical studies involving multiple clinical sites, central laboratories, and bioanalytical testing laboratories.
  • Experience contributing to regulatory submissions and development documentation.

Additional Skills/Experience/Requirements:
  • Deep understanding of regulated bioanalysis, assay validation, and global regulatory expectations.
  • Strong understanding of biomarker strategy and clinical development support.
  • Ability to integrate bioanalytical, PK, biomarker, and clinical data to inform development decisions.
  • Experience supporting both biologic and small molecule development programs preferred.
  • Experience with biomarker assays used for diagnosis, disease monitoring, target engagement, or pharmacodynamic assessment preferred.
  • Experience supporting global regulatory submissions across multiple geographic regions preferred.
  • Prior leadership experience in matrixed development organizations preferred.
  • Excellent communication, collaboration, and project leadership skills.
  • Ability to thrive in a fast-paced, cross-functional biotechnology environment.
  • All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

#LI-Remote
Travere is an EEO/AA/Veteran/Disability Employer
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$150,000.00 - $195,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.

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