Associate Scientist - Analytical Development
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 39,000 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 synthetic organic 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, works as an individual contributor in the Corporate Reference Standards Organization (CRSO). Job responsibilities include coordination of activities related to reference standards and related critical reagents and controls. The associate will work with CRSO scientists to evaluate and summarize characterization data, place orders for materials according to protocols, monitor and interact with global lab scientists to obtain characterization results, manage accelerated stability studies, create regulatory submission documents and other technical reports, and assist CRSO with a variety of other technical and business process deliverables.
- 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 when assessing data from a wide range of analytical methods and technologies. Displays comprehensive knowledge of various techniques (e.g., HPLC, GC, X-ray diffraction, Karl Fischer, UV, MS, biological assays, and compendial tests).
- Openly shares technical knowledge and key learning.
- Efficiently and effectively manages project deliverables to provide support for multiple projects at multiple phases.
- Establishes relationships with key business partners.
- Identifies internal and external customer requirements and develops solutions to meet customer needs.
- Maintains awareness of analytical science and pharmaceutical industry trends.
- Workday flexibility and effective at various forms of communication to enable participation in global team interactions.
- Demonstrates proficiency at data reporting, interpretation and trending
- Demonstrates good documentation skills with regard to authoring of technical and regulatory documents (e.g., technical reports, data integrity reviews, and submission documents).
Bachelor's and/or Master's degree in Chemistry, Pharmacy or similar technical field and pharmaceutical industry experience.
- Previous pharmaceutical industry experience (preferably 5+ years) required.
- Experience in synthetic small molecule, peptide, protein process and analytical development recommended.
- 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.
0-15% is typical
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability, and any other legally protected status as outlined in The Red Book.
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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-10283.
Lilly is an EEO/Affirmative Action Employer and 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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