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 35,000 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.

Overview of the organization

Bioproduct Research and Development (BRD) is an innovation-focused organization within Eli Lilly and Company. BRD is involved in key activities for the development of parenteral biologics drug substance and drug products including chemically-synthesized biomolecule drug products from pre-clinical phases through commercialization. Our dynamic department is made up of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers. We strive to identify, develop, and apply groundbreaking technologies to deliver maximum benefit to our patients. BRD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. BRD Analytical is a flexible, cross-functionally integrated, and capabilities driven team within BRD committed to providing state of the art measurement sciences to guide product and process understanding leading to optimized control strategies. Our mission is to elucidate understanding at molecular level, define critical quality attributes, integration of CMC knowledge, establish new platforms and technologies, and achieve regulatory acceptance to commercialize life changing medicines.

Main Purpose and Objectives of Position

As part of a multi-disciplinary team in BRD Analytical, the incumbent will provide oversight and support for GMP analytical testing (i.e. lot release and stability) for clinical trial materials, primary stability studies and technology transfers. Job responsibilities include providing oversight for the analysis of a variety of active pharmaceutical ingredients and dosage forms to evaluate stability, and support clinical trial materials; qualification, verification, and validation of analytical methods; transfer of analytical methods and techniques to third party testing laboratories; and reference standard support activities. These activities may include use of data and information in NuGenesis, Trackwise, Veeva Vault, and other systems.

Key Responsibilities

• Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. May participate in the development and review of procedures, policies, and training materials associated with the area.
• Demonstrates understanding and experience with GMP requirements

• Develops and maintains awareness and familiarity of ICH guidelines and other global regulations and guidance documents.
• Demonstrates strong analytical skills

• Demonstrates technical capability in reviewing and interpreting lot release and stability data for a select number of active pharmaceutical ingredients and pharmaceutical dosage forms in the LRL portfolio.
• Oversight of transfer/verification/qualification/validation of methods to support in-process, release, characterization analysis, and stability testing of active pharmaceutical ingredient and drug product.
• Experience with various analytical instrumentation and techniques (e.g., HPLC, CE, UV, various types of compendial testing)
• Demonstrates project management and communication skills

• Efficiently and effectively manages project deliverables to provide support for multiple projects in multiple phases of development.
• Effectively guide and oversee external work at collaboration partners.
• Generates, interprets, troubleshoots and effectively communicates (both in writing and orally) relevant information to management, team members, project leaders, and customers.
• Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives and third-party collaboration partners
• Demonstrates good documentation skills

• Author protocols, reports, and change controls to support lot release and stability testing, dating, temperature excursions and registration of API and drug product.
• Ensures the accuracy of the data/information entered into IT systems.
• Demonstrates proficiency at data reporting, interpretation, and trending (e.g., Empower chromatography software and electronic laboratory notebooks).
• Demonstrates understanding and experience with laboratory and stability systems and tools

• Demonstrates proficiency in performing basic operations in common informatics tools.
• Demonstrates capability and expertise in utilization of Trackwise to document events and changes; familiar with ServiceNow.

Educational Requirements

B.S. or M.S. in Chemistry, Pharmaceutics or related field and significant pharmaceutical industry experience.

Experience Requirements

For the above activities, an individual in this role requires:

• Fundamental knowledge of cGMP compliance requirements and pharmaceutical stability principles.
• Previous pharmaceutical industry experience (at least 8 years) required
• Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation.
• Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word) 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

License/Certificate Requirements

N/A

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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