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Bioanalysis Director Jobs (NOW HIRING)

Inotivco

Bioanalysis Scientist I

Rockville, MD

Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv's client base. * Ensure compliance is maintained ...

Inotiv

Bioanalysis Scientist I

Rockville, MD · On-site

Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv's client base. * Ensure compliance is maintained ...

Orum Therapeutics

$33.75 - $42.50/hr

Bioanalysis/PK Subject Matter Expert(SME) * R&D Clinical * IND/IB BioA, PK GLP/GCP FDA/EMA ... Execute an integrated role that bridges high-level scientific leadership and direct lab-based ...

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Bioanalysis Director information

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$44K

$122.4K

$186.5K

How much do bioanalysis director jobs pay per year?

As of Jul 11, 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 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.
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Bioanalysis Director jobs near you

Director of Bioanalytical Sciences

Xaira Therapeutics

South San Francisco, CA • On-site

$173K - $225K/yr

Other

Posted 14 days ago

Job description

Role Summary

We are seeking a Director of Bioanalytical Sciences to build and lead the bioanalytical strategy supporting our biologics portfolio across human and preclinical species, including non-human primate (NHP) and rodent models. This individual will be responsible for overseeing (both internally and externally) the development, qualification, and validation of bioanalytical methods spanning pharmacokinetics (PK), receptor occupancy (RO), and related biomarker and pharmacodynamic (PD) endpoints. As a key technical and strategic leader, the Director will partner extensively with contract research organizations (CROs) to deliver high-quality, regulatory-compliant data that informs candidate selection, translational strategy, and IND-enabling and clinical programs.

Key Responsibilities

  • Define and execute the analytical bioassay strategy for biologic programs across discovery, preclinical, and clinical stages, with emphasis on human, NHP, and rodent species.
  • Lead the development, optimization, qualification, and validation of ligand-binding assays (e.g., ELISA, MSD, ECL) and flow cytometry-based methods for PK, PD, receptor occupancy, and target engagement to support both non-GLP and IND-enabling GLP studies.
  • Direct the design and interpretation of DMPK and bioanalytical studies, integrating PK/PD and exposure data to support candidate selection and translational dose projection.
  • Serve as the primary technical and relationship lead for CRO partnerships - selecting, onboarding, and managing external labs; reviewing protocols, validation plans, and data packages; and ensuring on-time, high-quality deliverables.
  • Author and review bioanalytical sections of regulatory documents (IND, IB, study reports) and ensure methods meet GLP and current FDA/EMA/ICH M10 bioanalytical method validation guidance.
  • Establish robust assay qualification and validation frameworks, including acceptance criteria, troubleshooting strategies, and lifecycle management.
  • Collaborate cross-functionally with discovery biology, protein sciences, pharmacology, toxicology, clinical, and regulatory teams to align bioanalytical endpoints with program goals.
  • As pipeline evolves, build and manage a focused internal team. 

Required Qualifications

  • PhD in immunology, biochemistry, pharmacology, analytical chemistry, bioengineering, or a related life-science discipline.
  • More than 10 years of biotech/pharmaceutical industry experience in bioanalytical or DMPK development for biologics.
  • Deep expertise in bioanalytical method development, qualification, and validation for large molecules across human and preclinical species (NHP and rodent).
  • Demonstrated hands-on and strategic experience with PK, PD, and receptor occupancy assays, and with DMPK study design and interpretation.
  • Strong, proven track record of partnering with and managing CROs to deliver regulated bioanalytical data - a must.
  • Working knowledge of GLP and regulatory bioanalytical guidance (FDA, EMA, ICH M10).
  • Experience managing and mentoring staff scientists including in a matrixed environment.

Preferred Qualifications

  • Experience supporting IND filings and early clinical development for biologics.
  • Familiarity with platforms such as MSD/ECL, Gyrolab, Simoa, and multiparameter flow cytometry.
  • Experience integrating PK/PD modeling and translational data.
  • Prior experience building or scaling a bioanalytical function in a fast-paced or AI-enabled environment.

Compensation
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity.  The base pay range for this position is expected to be $173,000 - $225,000 annually; however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.

Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.

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