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Bioanalysis Director Jobs (NOW HIRING)

Orum Therapeutics

Bioanalytical Scientist

Lexington, MA · On-site

$150 - $180/day

As a key scientific lead, you will orchestrate the bioanalytical lifecycle - from internal method ... Execute an integrated role that bridges high-level scientific leadership and direct lab-based ...

UCB

Bioanalytical Scientific Manager (US)

Cambridge, MA · On-site

Make your mark for patients We are looking for a Principal Scientist or Associate Director - Bioanalytical Scientific Manager who is collaborative, scientifically rigorous, and solution-oriented to ...

Orum Therapeutics

Bioanalytical Scientist

Lexington, MA · On-site

$39.50 - $49.75/hr

As a key scientific lead, you will orchestrate the bioanalytical lifecycle - from internal method ... Execute an integrated role that bridges high-level scientific leadership and direct lab-based ...

UCB

Bioanalytical Scientific Manager (US)

Cambridge, MA · Hybrid

Make your mark for patients We are looking for a Principal Scientist or Associate Director - Bioanalytical Scientific Manager who is collaborative, scientifically rigorous, and solution-oriented to ...

MSD

Bioanalytical Scientist

Gaithersburg, MD · On-site

The Bioanalytical Scientist functions as a Bioanalytical Principal Investigator (BPI), providing ... If applicable, establish and monitor direct report performance and development goals, assign ...

CEDENT

Scientific Director Immunoassay

Malvern, PA · On-site

D. scientists in the development and validation of bioanalytical methods to support multiple ... Direct staff recruitment, onboarding, training, and career progression. * Ensure compliance with ...

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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 Jun 21, 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
Associate Director, Biomarker Analysis

Associate Director, Biomarker Analysis

Crinetics Pharmaceuticals

Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Job description

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Associate Director of Biomarker Bioanalysis will be responsible for the management of outsourced bioanalysis (Pharmacokinetics, PK) and biomarker activities including platform/assay selection, development, validation, and utilization in nonclinical and clinical development. The work will support projects at various stages of development thereby allowing the selected candidate to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego's biotechnology community.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
  • Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs for the successful development and/or implementation of bioanalysis (PK) and biomarker assays using either LC/MS, hybrid LBA-LC/MS assays or ligand-binding assay (LBA), in different settings (BA, IVD, LDT/RUO).
  • Develop appropriate biomarker analysis strategy for Crinetics' drug candidates in support of clinical and non-clinical studies based on study objectives.
  • Apply fit-for-purpose biomarker validation approach complied with FDA and global regulatory guidance under bioanalytical setting and follow CMS/CLIA and ISO guidance for the biomarker assays in clinical testing.
  • Review and finalize method validations protocols, stability studies, and bioanalytical reports. Participate in the periodic audit of bioanalytical CROs and ensure the accreditation compliance of the CLIA clinical testing labs.
  • Work with cross-functional colleagues in various programs to determine assay needs and manage assay selection, sample analysis, and reporting of results in a timeframe consistent with study and program goals.
  • Manage and negotiate scopes of work, budget, and payment schedules for outsourced bioanalysis/biomarker assay activities.
  • Review invoices against vendor contracts to ensure accuracy and service completion.
  • Contribute to bioanalytical report and relevant bioanalytical sections of CSRs, and other regulatory and submission documents.
  • Lead preparation of bioanalytical section in regulatory submission, e.g. author and/or review bioanalytical content, methods, and tabulated summaries for applicable IB, IND, and NDA.
  • Lead bioanalytical function on written responses to health authority bioanalytical queries.
  • Other duties as assigned.

Education and Experience:
  • Bachelor's degree in a relevant scientific field with 10+ years of industry experience in a bioanalytical/biomarker function in LCMS and ligand-binding assay (LBA) method development, sample analysis, and managing outsourced biomarker assay activities. Equivalent education and experience will be considered.
  • 7+ years of experience in a supervisory role is required.
  • Strong scientific and operational background in small and large molecule bioanalytical and biomarker method development, validation, data interpretation, reporting of sample analysis results.
  • Thorough understanding of bioanalytical and biomarker methodologies, GLP/GCLP requirements, ICH guidelines, and FDA guidance for bioanalytical assay validation and sample analysis.
  • Experience in CLIA clinical testing laboratory and central lab is a plus.
  • Proven ability to oversee validation work and sample analysis at CRO.
  • Highly knowledgeable on domestic and international service providers
  • Familiarity with all stages of nonclinical and clinical drug development, including prior experience in fit-for-purpose concept in assay development strategy.
  • Strong written, presentation and verbal communication skills.
  • Excellent track record of scientific publications is a plus.
  • Authoring experience in bioanalytical sections in regulatory submissions if a plus.
  • Experience in oversight of bioanalytical CROs in China is a plus.

Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 5-10% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws
Salary Range
The salary range for this position is: $158,000 - $197,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

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