Scientist Bioassay, GMP Testing Laboratories, BR&D

Eli Lilly and Company; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Scientist in Bioassay GMP Testing to join their dynamic team in Indianapolis. This role involves overseeing GMP laboratory areas, focusing on analytical method qualifications and stability testing for drug substances and products. With a commitment to innovation and excellence, you will leverage your technical expertise in analytical methods to support multiple projects. This forward-thinking organization values collaboration and is dedicated to making a difference in the lives of people worldwide. If you are passionate about advancing healthcare and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• 1-3 years of hands-on experience in Pharma/Biotech industry.
• BS in a science technical field or equivalent experience.

Responsibilities

• Perform and assess multiple analytical methods with technical excellence.
• Manage project deliverables and serve as project lead when necessary.
• Maintain awareness of analytical science and pharmaceutical industry trends.

Skills

Analytical Methods

ELISA

Biacore

qPCR

ddPCR

BioAssay

Data Reporting

Documentation Skills

Project Management

cGMP Compliance

Education

BS in a Science Technical Field

Equivalent Pharmaceutical Industry Experience

Tools

Empower

Nugenisis (eLN)

MS Excel

PowerPoint

MS Word

JMP

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 Scientist, Bioassay GMP Testing has 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.

Responsibilities:

• Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations.
• Makes sound technical decisions, and appropriately communicates these decisions to other scientists and management.
• Demonstrates technical excellence at performing and assessing multiple analytical methods. Displays comprehensive knowledge of instrument set-up, operation, and troubleshooting (e.g., ELISA, Biacore, qPCR, ddPCR, BioAssay).
• Openly shares technical knowledge and key learning.
• Use scientific expertise to assist with troubleshooting, laboratory investigations and problem resolution.
• Efficiently and effectively manages project deliverables to provide support for multiple projects at multiple phases.
• May serve as the project lead for one or multiple projects within the area.
• Establishes key relationships within BR&D, GQL, SMDD, and site QC Labs. Identifies internal and external customer requirements and develops solutions to meet customer needs.
• Maintains awareness of analytical science and pharmaceutical industry trends.
• Demonstrates proficiency at data reporting, interpretation, and trending (e.g., Empower, Nugenisis (eLN)).
• Demonstrates good documentation skills with regard to raw data recording and authoring of documents.

Basic Requirements:

• BS in a science technical field, or equivalent pharmaceutical industry experience. A minimum of 1-3 years of hands-on experience in Pharma/Biotech industry.

Additional Preferences:

• Fundamental knowledge of cGMP compliance requirements.
• Good documentation skills and ability to author and/or review standards, GMP guidelines, SOPs, templates, protocols, and other documentation.
• Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word, JMP) and the ability to compile, summarize and present information to diverse groups.
• Excellent communication skills and willingness to interact with laboratory personnel, contractors and management.
• Ability to troubleshoot problems and identify solutions.
• Ability to influence and partner with individuals outside of a formal reporting relationship towards realization of team goals.
• Customer-focused attitude.

Additional Information:

• Location: Indianapolis, IN (LTC North)
• 0-15% Travel is typical.