Full Time Assay Development Scientist Jobs in Indiana

Description

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 skills 

Work 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.