Advisor, Bioassay, GMP Testing Laboratories, BR&D

Eli Lilly and Company; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Advisor-Bioassay to join their dynamic team in Indianapolis. This role focuses on the qualification and validation of bioassays, ensuring compliance with cGMP standards while developing innovative strategies to enhance productivity. You will work collaboratively in a lab environment, leveraging your extensive experience in analytical development and problem-solving skills to deliver critical insights for therapeutic products. If you are passionate about making a difference in healthcare and thrive in a collaborative setting, this opportunity is perfect for you.

Qualifications

• 10+ years in analytical development and quality assurance in regulated industries.
• Basic knowledge of molecular biology and cell biology required.

Responsibilities

• Qualification and validation of cell-based bioassays for therapeutic proteins.
• Troubleshoot potency assay issues and provide feedback to bioassay scientists.

Skills

Analytical Development

Problem Solving

Molecular Biology

Cell Biology

cGMP Compliance

Education

Bachelor’s degree in Science or Engineering

Tools

Regulus

Data Integrity Tools

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

Position Summary:

The Advisor-Bioassay responsibilities for the GMP laboratory areas within the BR&D Analytical Development Organization, which is focused on analytical method qualifications, validations, and transfers, as well as analytical release and stability testing for GMP drug substance and drug product. Developing strategy, identifying new technology and tools, and technical capabilities to support the on-time delivery of the portfolio.

Responsibilities:

• Responsible for the qualification, validation and transfer of cell-based bioassays and surrogate bioassays such as ligand-binding ELISAs for the assessment of the biological activity of therapeutic antibodies and other proteins for methods installed with external and internal partners.
• Troubleshoot and solve problems with issues relating to potency assays, and for providing directive feedback to the bioassay scientists developing the methods through strong partnership and effective communication.
• Responsible and accountable for all types of cGMP documentation including analytical test methods (e.g., in Regulus), change controls, deviations, root cause investigations (RCIs), method qualification/validation reports, lab certification reports, and reference standard re-evaluation documentation.
• Identify and evaluate new technology, informatic tools, etc that enables productivity and efficiency to support the portfolio. Lead data integrity initiatives to deliver on regulatory and compliance expectations.
• Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Author regulatory and/or technical reports and memos.
• Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Monitor method performance, identify issues, and propose and lead resolutions in a cross functional technical team.

Basic Requirements:

• Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.
• 10+ years of relevant foundational experiences in analytical development, product and process development, quality assurance, or technical services in pharmaceutical or other regulated industries.

Additional Preferences:

• Requires basic molecular biology knowledge such as signal transduction, and gene expression; and cell biology skills such as cell culturing, cell counting, and cell banking. Experience in cGMPs, regulatory expectations, external/internal audits, and method transfers.

Additional Information:

• 0-10% travel required.
• Position requires 8 hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.

Physical Demands/Travel:

The physical demands of this job are consistent with a lab environment.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in a Laboratory.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.