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Bioanalytical Project Manager Jobs in Indiana (NOW HIRING)

Elanco

Research Scientist

Indianapolis, IN

We are seeking a skilled and detail-oriented Bioanalytical Scientist to join our Large Molecule ... to our project teams * Characterize, conjugate, and manage critical reagents (e.g., capture ...

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Bioanalytical Project Manager information

What does a Bioanalytical Project Manager do?

A Bioanalytical Project Manager oversees and coordinates bioanalytical studies, ensuring that projects are completed on time, within budget, and according to regulatory standards. They act as the main point of contact between clients, laboratory teams, and regulatory agencies, managing study timelines, resources, and data quality. Their responsibilities include planning project activities, monitoring progress, troubleshooting issues, and reporting results to stakeholders. They play a critical role in drug development by ensuring that bioanalytical testing meets scientific and compliance requirements.

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

To thrive as a Bioanalytical Project Manager, you need a strong background in bioanalysis, project management experience, and typically a degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (such as GLP/GCP), and project management tools like MS Project is essential. Excellent communication, leadership, and organizational skills help manage cross-functional teams and client expectations. These skills ensure the successful planning, execution, and delivery of complex bioanalytical projects within regulatory and timeline constraints.

What are some common challenges faced by Bioanalytical Project Managers, and how can they be addressed?

Bioanalytical Project Managers often face challenges coordinating timelines across multiple stakeholders, such as laboratory teams, clients, and regulatory bodies. Managing shifting project priorities and ensuring data integrity under tight deadlines can also be demanding. To address these challenges, effective communication, proactive risk management, and strong organizational skills are essential. Regular status meetings, clear documentation, and building strong relationships with both internal and external partners help keep projects on track and ensure compliance with regulatory standards.

What is the difference between Bioanalytical Project Manager vs Bioanalytical Scientist?

AspectBioanalytical Project ManagerBioanalytical Scientist
CredentialsBachelor's or Master's in Life Sciences, PMP often preferredDegree in Biology, Chemistry, or related field; PhD or Master's common
Work EnvironmentProject teams, client meetings, coordination rolesLaboratory research, data analysis, method development
Employer & Industry UsagePharmaceutical, biotech companies, CROsResearch labs, pharmaceutical companies, CROs

The Bioanalytical Project Manager oversees project timelines, budgets, and client communication, ensuring successful completion. In contrast, the Bioanalytical Scientist focuses on experimental design, data collection, and method development. Both roles are essential in the bioanalytical industry but differ in responsibilities and daily tasks.

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Bioanalytical Project Manager jobs near you
Lab Supervisor - Bioanalytical (Ligand Binding Assays)

Lab Supervisor - Bioanalytical (Ligand Binding Assays)

B2S Life Sciences

Franklin, IN • On-site, Remote

Full-time

Posted 27 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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