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 support for GMP analytical testing (i.e., lot release and stability) for clinical trial materials, primary stability studies and technology transfers. Job responsibilities include Data Integrity review of analytical data for 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.
- 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 basic understanding of the following:
- Develops/maintains awareness and familiarity of ICH guidelines and other global regulations and guidance documents per GMP requirements.
- Review of lot release and stability data for active pharmaceutical ingredients and pharmaceutical dosage forms in the LRL portfolio.
- Various analytical instrumentation and techniques (e.g., HPLC, CE, UV, various types of compendial testing)
- Demonstrates project management and other key analytical skills.
- Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives and third-party collaboration partners.
- Author protocols and stability reports 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.
- Experience with laboratory and stability systems/ tools in performing basic operations in common informatics tools
B.S. or M.S. in Chemistry, Pharmaceutics, Biochemistry, Biotechnology, or a related field
For the above activities, an individual in this role requires:
- Fundamental knowledge of cGMP compliance requirements and pharmaceutical stability principles.
- 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
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 ( [email protected] ) 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.
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