Position 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.
Key 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. Requirements: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.Key Competencies
Leadership & team development Technical expertise in bioanalysis Problem-solving & critical thinking Strong communication & stakeholder management Attention to detail & data integrity focus Organizational and time management skillsWork Environment
Laboratory-based role within a regulated CRO environment. May require occasional extended hours to meet study deadlines. Interaction with cross-functional teams, including QA, project management, and clients. Read LessOnsite in Franklin, Indiana
Principal Function: The Scientist III Method Development is a key member of the Bioanalytical Assay Development and Validation team. This team has overall responsibility for the development, optimization, pre-study validation and in-study execution of bioanalytical methods to support clients’ programs for the development of biotherapeutic drug candidates. Most often this work is performed using critical reagents generated by B2S Life Sciences. The range of bioanalytical support includes early phase ADME investigations, reagent optimization, generation of optimal matched pair of antibodies, method qualification, and non-GLP & GLP sample analysis. The individual in this role will help ensure B2S bioanalytical assays are engineered appropriately to ensure quality and regulatory standards for Good Laboratory Practice (GLP) compliance are followed.
Scientist III designs and executes experiments, with minimal supervision, which complement the company's capabilities in custom critical reagents to enable clients to efficiently make data-driven decisions for optimal analytical outcomes to support biotherapeutic drug development. The individuals will have the ability to work independently with little or no supervision with a focus on bioanalytical science and capable of troubleshooting assay issues efficiently. In addition the individual will have the ability to work across different therapeutic areas to manage multiple projects concurrently.
Essential Duties and Responsibilities
Plan, execute, troubleshoot and analyze experiments and interpret scientific findings. Troubleshoot existing analytical methods. Work independently in a collaborative team environment Compile scientific data (including analysis and technical writing) Record and note the experimental processes. Report and treat data with prominent level of integrity and ethics. Possess good oral communication and willing to communicate frequently with clients Comply with application able regulations (GXP) Maintain proper records in accordance with standard operating procedures (SOPs) and policies. Dedicated to bioanalytical science and work to grow expertise to maintain current knowledge with respect to industry and regulatory trends. Design and perform scientific experiments with a pre-defined goal including developing new methodologies, protocols, and/or test procedures that contribute to core group research goals. Seek bioanalytical solutions that are innovative yet simple to execute. Willing to publish work in scientific journals and make presentations at meetings. Maintain laboratory equipment, as needed. Develop new methodologies, protocols, and/or test procedures that contribute to core group research goals and reflect expert knowledge. Willingness to mentor junior staff and team members Maintains laboratory equipment, as needed. Performs other duties as assigned. Requirements:Education and/or Experience
Bachelor’s Degree (B.S./B.A) or Master’s Degree (M.S.) in a related science with at least four-years of direct laboratory experience Doctorate Degree (P.H. D.) in biology or related degree with zero to two years of direct laboratory experience. An equivalent combination of related education and required work experience will be considered.Laboratory experience in developing and troubleshooting LBAs and cell culture bioassays is desired.Experience in a good laboratory practice (GLP) and good clinical practice (GCP) environment is desired. Experience with biotherapeutic bioanalysis at a contract research organization (CRO) is desired. The ability to adapt and conform to shifting priorities and demands and execute accordingly. Strong organizational and communication skills, both written and verbal. The position may require evening and weekend work, domestic travel, and a valid driver’s license. Computer software skills required, including Microsoft Office Suites. Individuals must be able to perform each essential duty according to the requirements of the Organization. The requirements listed above are representative of the knowledge, skills, and/or abilities required.Competencies:
Quality and Quantity – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality; Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly but efficiently. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures. Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Oral and Written Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Reads with the ability to interpret written information.Other Skills and Abilities
Ability to adapt and conform to shifting priorities and demands and execute accordingly. Strong organizational and communication skills, both written and verbal. Computer software skills required include Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, OneDrive, OneNote, SharePoint, and Teams.Physical Demands
Ability to stand less than 1/3 of the time. Ability to walk less than 1/3 of the time. Ability to sit more than 2/3 of the time. Ability to talk or hear from 1/3 to 2/3 of the time. Ability to lift 20 lbs. less than 1/3 of the time.Work Environment
The work environment is in an office/laboratory environment. Travel up to 5% percent of the time. Frequent use of a computer is necessary. This position requires working independently, as well as part of a team. The noise level in the work environment is usually moderately loud and has moderate temperatures. Personal protective equipment must be worn in designated lab areas: closed-toed shoes, laboratory coat, safety goggles, and gloves. This position requires the use of all general office equipment. Potential exposure to pathogensPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Read Less