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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 Indiana? For Bioanalysis Director jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Bioanalysis Director jobs in Indiana look for? The top searched job categories for Bioanalysis Director jobs in Indiana are:
Bioanalysis Director jobs near you
Lab Supervisor (Bioanalytical)

Lab Supervisor (Bioanalytical)

Kelly Services

Franklin, IN

$80K - $90K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 22 days ago

Job description

Lab Supervisor (Bioanalytical)
Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting opportunity as a Lab Supervisor (Bioanalytical) with a biotechnology and life science leader.
Location: Onsite in Franklin, IN
Duration: Direct Hire
Schedule: Mon-Fri, 1st shift
Compensation: $80,000-90,000/yr
SUMMARY
The Lab Supervisor, Bioanalytical (Ligand Binding Assays), is responsible for overseeing the daily operations of a regulated bioanalytical laboratory supporting ligand binding assay (LBA) studies within a Contract Research Organization (CRO). This role ensures high-quality, compliant execution of immunoassays (e.g., ELISA, MSD) used in pharmacokinetic (PK), immunogenicity (ADA), Neutralizing Antibody (Nab) and biomarker analysis in support of preclinical and clinical programs. 
The supervisor provides technical leadership, staff development, and operational oversight to ensure delivery of accurate, timely, and regulatory-compliant data in accordance with GLP, GCP, and applicable regulatory guidance. 
RESPONSIBILITIES
Laboratory Operations & Supervision 
  • Supervise and coordinate daily bioanalytical lab activities supporting LBA workflows. 
  • Ensure studies are executed on time and according to approved protocols, SOPs, and client expectations. 
  • Monitor assay performance, troubleshoot issues, and ensure data integrity. 
  • Allocate resources (staff, instruments, reagents) to meet study timelines and priorities. 
  • Maintain a safe and efficient laboratory environment. 
  • Provides support for laboratory operations by addressing and resolving issues that may arise. 
  • Other duties as assigned. 
Technical Leadership (LBA Focus) 
  • Provide subject matter expertise in ligand binding assay platforms (ELISA, ECL/MSD, etc.). 
  • Assists with method qualification, validation, and sample analysis. 
  • Review assay data, identify trends, and guide troubleshooting/root cause investigations. 
  • Ensure adherence to regulatory expectations for assay performance (accuracy, precision, sensitivity, selectivity). 
Quality & Compliance 
  • Ensure compliance with GLP, GCP, 21 CFR Part 11, and relevant regulatory guidance (FDA, EMA). 
  • Serves as Test Site Management for reports, audits, and investigations, as applicable. Support audits (internal, client, regulatory inspections) and address findings with appropriate CAPAs. 
  • Ensure proper documentation practices and data integrity standards. 
Staff Management & Development 
  • Supervise, coach, and mentor bioanalytical scientists and technicians. 
  • Conduct performance reviews, training plans, and career development initiatives. 
  • Ensure staff are trained and qualified on applicable methods, instrumentation, and SOPs. 
  • Foster a collaborative, high-performance, and accountable team environment. 
Continuous Improvement 
  • Identify and implement process improvements to increase efficiency, quality, and throughput. 
  • Support adoption of new technologies and automation within LBA workflows. 
  • Contribute to SOP development, revision, and standardization. 

QUALIFICATIONS
Education 
  • Bachelor’s degree in Biology, Biochemistry, Immunology, or related field (Master’s preferred).
Experience 
  • 5–8+ years of experience in bioanalytical laboratory environments, preferably within a CRO. 
  • 2+ years of supervisory or team leadership experience. 
  • Strong hands-on experience with ligand binding assays (ELISA, MSD, Gyrolab). 
Technical Skills 
  • Deep understanding of LBA method development, validation, and sample analysis. 
  • Experience with PK, ADA (screening, confirmatory, titer), and biomarker assays. 
  • Familiarity with laboratory data systems (e.g., LIMS, Watson, SoftMax Pro, Discovery Workbench). 
  • Strong data analysis and troubleshooting skills.
Regulatory Knowledge 
  • Working knowledge of GLP/GCP and regulatory guidance for bioanalytical methods (ICH, FDA, EMA). 
  • Experience supporting audits and inspections. 
Preferred Qualifications 
  • Experience in large molecule bioanalysis, ligand binding assays (monoclonal antibodies, biologics). 
  • Exposure to automation platforms or high-throughput assay systems. 
  • Experience with electronic lab notebooks and data integrity best practices. 
  • Management, supervisory experience preferred. 
  • P#1

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States. 
Send resumes to: Jacqueline.Sayoc@KellyScientific.com
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
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