Pk Immunogenicity Jobs (NOW HIRING)

Description:

Location: Onsite in Franklin, Indiana. 

Position Summary 

The ELN Administrator is responsible for the management, creation, maintenance, and continuous improvement of Electronic Lab Notebook (ELN) templates used at B2S LifeSciences workflows within a regulated Contract Research Organization (CRO). This role supports scientific and operational teams by translating study protocols, assay methods, and regulatory requirements into standardized, compliant, and user-friendly electronic templates to support our Logistics, Metrology, Chemical Reagent Team, and Bioanalytical groups.  

The ELN Administrator serves as the Technical Lead and SME (Subject Matter expert) for the Sapio ELN platform. 

The position plays a critical role in ensuring data integrity, consistency, and efficiency in bioanalytical study execution, while maintaining compliance with GLP, GCP, and 21 CFR Part 11 requirements.  

Key Responsibilities 

ELN Template Development & Maintenance 

• Design, build, and maintain ELN templates for ligand binding assays, including PK, immunogenicity (ADA), and biomarker workflows. 
• Design, build, and maintain ELN templates for Critical Reagent workflows. 
• May require user to translate study protocols, assay methods, and SOPs into structured, standardized ELN formats. 
• Ensure templates support accurate, complete, and consistent data capture. 
• Maintain version control and lifecycle management of ELN templates. 
• Serves as a Subject Matter Expert (SME) for ELN Template generation, qualification and implementation within a regulatory environment.  
• Other duties as assigned.  

Regulatory Compliance & Data Integrity 

• Ensure all ELN templates comply with GLP, GCP, and 21 CFR Part 11 requirements for electronic records and signatures. Other regulations may apply.  
• Partner with Quality Assurance (QA) to ensure templates meet audit and inspection readiness standards. 
• Incorporate data integrity principles (ALCOA+) into all template designs. 
• Support audit preparation and responses related to ELN processes. 

Cross-Functional Collaboration 

• Work closely with various B2S team members  to understand workflow requirements. 
• Collaborate with IT and ELN system administrators (internally & externally) to implement template functionality and updates. 

Process Improvement & Standardization 

• Identify opportunities to improve template usability, automation, and efficiency. 
• Drive standardization across assays, studies, and clients where appropriate. 
• Contribute to SOP development and best practices for ELN usage. 

User Support & Training 

• Provide guidance and support to laboratory staff on ELN template usage, training and deployment.  
• Assist in troubleshooting template-related issues. 
• Develop training materials and conduct user training sessions as needed. 

Documentation & Change Management 

• Manage template change requests and document all updates in accordance with change control procedures. 
• Maintain clear documentation of template specifications and configurations. 
• Other duties as assigned. 

Requirements:

Education 

• Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field or equivalent combination of scientific and administrative experience. 

Experience 

• 2–5+ years of experience in a regulated laboratory, CRO, or pharmaceutical environment. 
• Experience working with Electronic Lab Notebooks (e.g., IDBS E-Workbook, Benchling, LabWare ELN, or similar. Sapio Is preferred). 
• Experience in developing Electronic Lab Notebook templates is preferred. 
• Familiarity with bioanalytical workflows, preferably ligand binding assays. 

Technical Skills 

• Strong attention to detail with the ability to translate scientific procedures into structured digital templates. 
• Proficiency in data structuring, formatting, and workflow logic. 
• Experience with document control and versioning systems. 
• Basic understanding of assay workflows (ELISA, MSD, etc.) is highly desirable. 

Regulatory Knowledge 

• Understanding of GLP, GCP, and 21 CFR Part 11 requirements. 
• Familiarity with data integrity principles (ALCOA+). 

Preferred Qualifications 

• Experience specifically supporting ligand binding assay (LBA) environments (PK, ADA, biomarkers). 
• Experience using an Electronic Laboratory Notebook system, generation and versioning of templates and Exposure to LIMS and other laboratory informatics systems. 
• Experience with validation of computerized systems (CSV) or template validation. 
• Prior experience in template automation or workflow optimization. 

Key Competencies 

• Exceptional attention to detail and organizational skills 
• Strong written and verbal communication 
• Ability to collaborate across scientific, QA, and IT teams 
• Problem-solving and process improvement mindset 
• Adaptability in a fast-paced, regulated environment 
• Commitment to quality and compliance 

Work Environment 

• Office or hybrid role within a CRO supporting laboratory operations. 
• Frequent interaction with laboratory scientists, QA, and IT teams. 
• Work may be deadline-driven, aligned with study start-up timelines.