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In Lims Validation Jobs in Indiana (NOW HIRING)

Elanco

Engineer, IT Manufacturing QC Labs

Clinton, IN · On-site

$68K - $88K/yr

... ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data ... in a validated state, compliant with GxP and data integrity requirements. * Stakeholder ...

TEKsystems

LabVantage LES Engineer

Clinton, IN · Hybrid

$50 - $70/hr

... (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data. • ... in a validated state, compliant with GxP and data integrity requirements. • Stakeholder ...

INCOG

Senior MES Engineer

Fishers, IN

$97K - $134K/yr

Provide technical support to Computer System Validation (CSV) activities, including MES ... LIMS systems in a regulated environment. Familiarity with analytics and reporting tools such as ...

INCOG

QC Chemist, 3rd Shift

Fishers, IN

... materials, in-process samples, finished product, and stability samples according to validated ... LIMS, JMP, Minitab, etc.) Additional Preferences: * Experience with Continuous Improvement, Six ...

Novartis

Supervisor, QC Chemistry

Indianapolis, IN

$88K - $132K/yr

Indianapolis, IN #LI-Onsite About this role: In this people management role, the QC Chemistry ... Design and execute method transfers/qualifications/validations based on Regulatory guidelines and ...

Bureau Veritas

Develop, validate, and document standard operating procedures for sample handling, ensuring ... LIMS, electronic laboratory notebooks, etc. * Detailed record keeping of daily experiments in ELNs

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN

$94K - $129K/yr

... Validation (CSV) activities, including MES qualification and data integrity assessments. · Work ... , and LIMS systems in a regulated environment. * Familiarity with analytics and reporting tools ...

Bureau Veritas

Analytical Chemist II

Indianapolis, IN · On-site

Develop, validate, and document standard operating procedures for sample handling, ensuring ... LIMS, electronic laboratory notebooks, etc. * Detailed record keeping of daily experiments in ELNs

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All JobsIn Lims Validation JobsIn Lims Validation Jobs in Indiana

In Lims Validation information

What is the difference between In Lims Validation vs Laboratory Technician?

AspectIn Lims ValidationLaboratory Technician
CertificationsGMP, GLP, Validation certificationsTypically relevant certifications include Lab Technician or related training
Work EnvironmentQuality assurance, validation labs, regulated industriesLaboratories performing tests and experiments
Job FocusEnsuring LIMS systems meet regulatory standardsPerforming tests, recording data, maintaining lab equipment

In Lims Validation professionals focus on validating Laboratory Information Management Systems to ensure compliance with industry standards, while Laboratory Technicians perform routine testing and data collection. Both roles are essential in regulated labs but differ in scope and responsibilities.

What is an In Lims Validation specialist job description?

An In Lims Validation specialist is responsible for ensuring that laboratory information management systems (LIMS) are properly validated and compliant with industry standards. They develop validation protocols, execute testing, document results, and collaborate with quality assurance teams to maintain data integrity and system functionality. Proficiency in validation processes, regulatory requirements, and LIMS software is essential for this role.
What are popular job titles related to In Lims Validation jobs in Indiana? For In Lims Validation jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching In Lims Validation jobs in Indiana look for? The top searched job categories for In Lims Validation jobs in Indiana are:
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In Lims Validation jobs near you

Lab Supervisor - Bioanalytical (Ligand Binding Assays)

B2S Life Sciences

Franklin, IN • On-site, Remote

Full-time

Re-posted 23 days ago

Job 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.

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