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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 ...

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 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

Bioanalysis Scientist I

Inotivco

Rockville, MD

Full-time

Medical, Dental, Retirement, PTO

Posted 9 days ago

Job description

Responsibilities and Duties
Corporate
Adherence to laboratory health and safety procedures
Adherence to Standard Operating Procedures (SOPs)
Adherence to applicable company policies and guidelines
Adherence to federal and/or local regulations, as applicable

Position Requirements

Education and experience

  • Ph.D. or MSc in immunology, cell biology, molecular biology, biochemistry, biotechnology, or related field, with 3-5 years of bioanalytical experience in pre-clinical/clinical CRO.
  • Knowledge/experience working with biotherapeutics, biomarkers and large molecules (e.g., proteins, peptides, monoclonal antibodies, oligonucleotides) is required.
  • Experience in method development and validation of large molecules for cell and gene therapy, pharmacokinetic (PK), toxicokinetic and immunogenicity (ADA and Nab).
  • Experience with genomics platforms (e.g., qPCR, ddPCR, NGS) and ligand binding assay platforms (ELISA, ELISPOT, MSD, and Luminex), and instruments following lab safety guidelines and using appropriate aseptic techniques.
  • Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents.
  • Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects.

Skills and abilities

  • Demonstrated expertise in bioanalytical best practices and processes.
  • Understanding of GLP/GCP/GMP/GCLP regulations; ability to apply practices daily.
  • Excellent written and verbal communication skills (English required); open, interactive style that facilitates high levels of trust.
  • Exceptional project management and organizational skills.
  • Exceptional partnering and collaboration skills with stakeholders at all levels.
  • Superior interpersonal skills that demonstrate high levels of emotional intelligence and critical thinking.
  • Self-starter, capable of working independently to generate desired results.
  • Proficiency with MS Office Suite products.
  • Expert knowledge of molecular biology and various immunoassay platforms (e.g., fluorescence and chemiluminescence) including PCR instruments for biotherapeutics and biomarkers.
  • Experience with LIMS system and data acquisition software.

Performance requirements

General

  • Ability to read, write, speak and understand English

Physical Activity

  • Moderate physical activity. This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day)
  • Able to wear latex or nitrile gloves, and safety glasses as required.
  • Ability to read and understand applicable materials
  • Manual dexterity to operate laboratory equipment and calculator/computer
  • Able to read and interpret test results and instrument specifications

Working Conditions

  • Work is normally performed in a typical interior office or laboratory environment
  • Work environment involves exposure to potentially dangerous materials and situations that require following safety precautions and may include use of protective equipment
  • This position will frequently involved irritants, acids, bases, and other hazardous chemicals, flammable materials and bio-hazards. Due to exposure to hazardous biological material (which may include HIV positive specimens), immunization to Hepatitis B and/or other diseases may be a requirement.

Specific

  • Be responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and protein), validation, and sample management/analysis in support of preclinical and clinical drug development, and biotherapeutics services tasks by maintaining the integrity of data in compliances with standard operating procedures (SOPs) and GxP (GLP, GCP, GMP, GCLP) regulatory guidelines.
  • Identify and develop assays to support biological characterization of large molecules and novel technologies to improve the assays and facilitate endpoint evaluation for pre-clinical studies.
  • 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, continuing Inotiv's phenomenal track record of successful FDA audits.
  • Regularly perform method development, validation, sample analysis, and troubleshoot failures with internal and external project teams in a collaborative and supportive manner.
  • Create, maintain, and improve standardized tools for method development and validation activities; identify opportunities for automation to increase speed and efficiency.
  • Identify new approaches, methodology, and/or the advent of state-of-the-art equipment.
  • Act as study principal investigator which requires timely feedback to clients on projects.
  • Provide directions and guidance to new and junior scientists.
  • Author and review technical documents (protocols, analytical reports, SOPs and raw data summaries).
  • Train new staff to conduct experiments and troubleshoot experimental issues
  • Presents research data/posters in scientific meetings and publish scientific data in reputed journals
  • Review all protocols design prior for which he is assigned
  • Operate, maintain, and troubleshoot complex analytical instruments and techniques.
  • Perform other job duties, as assigned.

Professional

  • Attend continuing education courses or webinars, as appropriate.

The pay range estimated for this position is $80,100- $105,500.00 annually. Please note that rates/salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

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