1

Biomarker Operation Manager Jobs in Indiana (NOW HIRING)

Biomarker Operation Manager information

What are the key skills and qualifications needed to thrive as a Biomarker Operation Manager, and why are they important?

To excel as a Biomarker Operation Manager, you need a solid background in biomedical sciences or a related field, experience in clinical trials, and a deep understanding of biomarker development and validation. Familiarity with laboratory information management systems (LIMS), regulatory compliance tools, and project management software is typically required. Exceptional organizational, communication, and leadership skills are crucial for coordinating cross-functional teams and managing complex projects. These competencies ensure the timely, compliant, and efficient delivery of biomarker strategies that are critical to successful clinical research and drug development.

What is the difference between Biomarker Operation Manager vs Biomarker Scientist?

AspectBiomarker Operation ManagerBiomarker Scientist
Primary RoleOversees biomarker assay operations, manages teams, ensures quality controlConducts biomarker research, develops assays, analyzes data
Required CredentialsBachelor's or Master's in life sciences, project management experienceAdvanced degree (PhD or Master's), laboratory expertise
Work EnvironmentClinical labs, research organizations, biotech companiesResearch labs, academic institutions, pharmaceutical companies
Industry UsageCommon in clinical trial settings and biotech firmsPrimarily in research and development roles

The Biomarker Operation Manager focuses on managing biomarker assay operations and team coordination, ensuring quality and compliance. In contrast, the Biomarker Scientist is dedicated to conducting research, developing new assays, and analyzing data. Both roles require scientific credentials, but their daily responsibilities and work environments differ significantly.

What are some common challenges faced by a Biomarker Operation Manager when coordinating multi-site clinical trials?

A Biomarker Operation Manager often encounters challenges such as ensuring consistent sample collection and processing across multiple sites, maintaining strict compliance with regulatory standards, and facilitating effective communication between cross-functional teams. Managing logistics for timely shipment and storage of biological specimens, as well as addressing unforeseen protocol deviations, are also key difficulties. Successfully navigating these challenges requires strong organizational skills, attention to detail, and proactive problem-solving to support seamless trial execution.

What does a Biomarker Operation Manager do?

A Biomarker Operation Manager oversees the planning, execution, and management of biomarker studies within clinical trials. They coordinate with cross-functional teams to ensure the proper selection, collection, analysis, and reporting of biomarker data. Their role is crucial in ensuring compliance with regulatory requirements, timelines, and scientific objectives. Biomarker Operation Managers also work closely with external vendors and laboratories to ensure high-quality and timely data delivery, supporting the overall drug development process.
What are popular job titles related to Biomarker Operation Manager jobs in Indiana? For Biomarker Operation Manager jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Biomarker Operation Manager jobs in Indiana look for? The top searched job categories for Biomarker Operation Manager jobs in Indiana are:
What cities in Indiana are hiring for Biomarker Operation Manager jobs? Cities in Indiana with the most Biomarker Operation Manager job openings:

Associate Scientist- Clinical Chemistry and Biomarker Research

Eli Lilly and Company

Indianapolis, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 63 frontline employees who took The Breakroom Quiz

11th of 86 rated pharmaceutical


Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Our clinical chemistry and biomarker laboratory within Cardiometabolic Research (CMR) generates high-quality data across preclinical and clinical samples - to characterize and evaluate the safety, efficacy, and pharmacology of therapeutic candidates from discovery through clinical development. We are strengthening this capability and are seeking a hands-on scientific team leader to establish reliable, high-quality delivery, build a collaborative and resilient team, and adapt to shifting portfolio priorities.
Purpose of the Job
This is a senior, hands-on leadership role that leads and coordinates the people and day-to-day operations of the clinical chemistry laboratory and owns the review, interpretation, and translation of analytical results into clear, actionable conclusions for therapeutic-area scientists, study teams, and cross-functional partners. The emphasis is team leadership and interpretation rather than routine bench execution; however, this is a working leader who retains hands-on competency and steps at the bench as needed to train staff, cover workload, and lead by example. Success depends on strong delegation, a collaborative team culture, and an out-of-the-box approach suited to a discovery setting that does not fully mirror a standard clinical chemistry laboratory. A central objective is to build and standardize operations - coordinating closely with all biomarker research labs on shared samples and hand-offs - and to restore dependable, on-time turnaround.
Key Responsibilities
1. Team Leadership, Delegation & Culture - Lead, coordinate, and develop the laboratory team of employees and contractors. Delegate effectively across the team, balance and schedule workload, and provide day-to-day coaching, mentoring, training, and competency development. Champion a collaborative, accountable, high-performing culture, and establish clear roles, expectations, and ways of working as the group rebuilds.
2. Interpretation & Translation of Results - Review and interpret clinical chemistry, hematology, pathology and biomarker data and translate results into clear conclusions and their biological and study context for therapeutic-area scientists, study directors, and cross-functional partners. Contextualize findings against species-specific reference intervals and expected physiology, follow up on anomalies, present result summaries, and serve as the laboratory's point of contact for data interpretation.
3. Technical Leadership & Hands-On Support - Maintain personal competency in core clinical chemistry, pathology and biomarker methods. Perform, troubleshoot, and validate assays as needed to support the team, cover capacity, and onboard new tests; provide at-the-bench technical guidance; establish, deliver, and assess staff training and competency programs; and serve as a technical resource for laboratory personnel, study teams, veterinarians/pathologists, and external partners.
4. Quality, Compliance & Data Integrity - Oversee QC and data review to ensure high quality and eliminate errors. Author and revise SOPs/SLPs, methods, and guidelines; ensure adherence to applicable standards and quality systems (e.g., GLP/GCP/GCLP/CLIA/CAP as applicable); own investigations, corrective and preventive actions, and audit and inspection readiness.
5. Laboratory Operations & Standardization - Direct daily workflow, sample management and chain-of-custody, instrument readiness, inventory, and laboratory organization and safety - primarily through the team. Drive standardization and automation, and coordinate closely with the biomarker research labs on shared samples, hand-offs, and consistent standards across projects that span multiple groups. Set and track quality metrics, re-establish reliable on-time delivery, and evaluate, validate, and onboard new tests, technologies, instrumentation, and laboratory information systems (e.g., LIMS).
6. Partner, Vendor & Contractor Management - Build and maintain strong relationships with internal client scientists and study teams; understand their needs and set clear expectations and timelines. Provide scientific and technical oversight of contractors and of work conducted at third-party organizations / CROs, and act as the primary point of escalation for technical and delivery issues.
7. Process Optimization & Innovation - Champion process improvement, standardization, and automation to improve throughput, reproducibility, and data quality. Bring an out-of-the-box perspective to a discovery environment that does not fully mimic a standard clinical chemistry setting, adapting methods and evaluating new technologies - including artificial intelligence (AI) tools - to meet evolving research needs.
Basic Requirements
  • Bachelor's degree in biology, medical technology, clinical laboratory science, biochemistry, or a related scientific field
  • 5+ years of demonstrated hands-on experience performing clinical chemistry and pathology or related analytical laboratory assays
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills / Preferences
  • Deep understanding of the clinical chemistry world - analytes, assay principles, instrumentation, reference intervals, and physiological interpretation of results.
  • Veterinary or preclinical clinical pathology experience - animal models, species-specific hematology and clinical chemistry, and comfort partnering with veterinarians, study directors, biologists, and pathologists in a discovery setting.
  • Demonstrated team leadership or supervisory experience with the competency to train, assess, and supervise staff performing this work.
  • Creative, out-of-the-box problem-solver comfortable in a discovery environment that does not fully mirror a standard clinical chemistry laboratory, and a strong collaborator across teams.
  • Hands-on proficiency across clinical pathology methods, including automated hematology and chemistry analyzers and blood and bone-marrow smear preparation and review, with the ability to train others.
  • Board or laboratory certification (e.g., ASCP MT/MLS or veterinary equivalent) is not required in this discovery environment but is welcomed; a certification-grade, clinical-lab approach - regimented rigor and high documentation standards - is highly valued.
  • Working knowledge of quality systems, SOP authoring, and data integrity, with familiarity with GLP/GCP/GCLP/CLIA/CAP as applicable.
  • Experience with laboratory information management systems (e.g., Provantis, Signals) and proficiency with Excel and data-visualization tools. Innovative perspective to adapt and welcome the AI-revolution.
  • Familiarity with biomarker assay formats (e.g., ELISA, MSD, immunoassays) is a plus.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly

What Eli Lilly and Company employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom


Eli Lilly logo

About Eli Lilly

Sourced by ZipRecruiter

Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Indianapolis, IN, US

Year founded

1876