Req ID 42325 Title Chemist-Large Molecule Formulation City Indianapolis State / Province Indiana Country United States Region North America Company Overview 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.
Responsibilities The Bioproduct Research and Development organization strives to deliver creative medicines to patients through the development and commercialization of insulins, monoclonal antibodies, novel therapeutic proteins, and peptides. This organization is a multidisciplinary group that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, scientists have full access to our scientific excellence and engineering capabilities.
As a Formulation Scientist/Chemist in Drug Product Development, you are responsible for conducting pre-formulation characterization, formulation of parenteral and novel delivery systems, commercial development studies and technology transfer to manufacturing sites for assigned small and large molecule projects. The scientist will interact closely with other scientists and may be an integral part of multidisciplinary teams that provide support for product and process development as well as working with Discovery, API development, Analytical Development, Delivery, Device and Connected Solutions (DDCS), CT Operations and Manufacturing. Additional responsibilities might include:
Good laboratory skills and familiarity with formulation, analytical/biophysical techniques and methods capability and hands-on experience with laboratory instruments
Involved in managing formulation aspects of projects, including experimental design, execution, and efficient use of data to plan next steps, ability to multi-task and collaborate effectively across CMC functions and with medical, marketing, PK/PD, and toxicology
Conduct pre-formulation characterization and formulation studies to develop clinical formulations. Provide support for successful manufacture of clinical supplies.
Conduct studies to support any manufacture of supplies for GLP studies and needed compatibility testing.
Good judgment and escalation of technical issues in a timely manner.
Authorship of technical reports and regulatory document (IND/CTA, BLA).
Present data at formulation and/or other technical forums.
42325BR Basic Qualifications
Bachelor of Science
1 years of relevant industry experience
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Familiarity of CT and commercial platform processes, working knowledge of CMO operations
Technology transfer of formulation and/or manufacturing process as appropriate to sites for CT and/or commercial manufacture.
Work effectively with the Bioprocess organization in the definition of the API matrix and in the development of the formulated bulk.
Work effectively with Analytical Development in the definition of Drug Product physical and chemical stability properties as well as coordination of analytical testing support.
Familiarity of API manufacturing process and impact on drug product Critical Quality Attributes.
Conduct commercial development studies collaborating effectively with functions such as Engineering, Statistics, TS/MS and manufacturing sites.
Keep abreast of relevant new technologies / capabilities and regulatory initiatives / requirements. Implement new capabilities, as appropriate.
Work effectively with external partners on outsourcing efforts and research collaborations.
Ensure work is aligned with all relevant PR&D Development Quality, regulatory and HSE requirements.
Good communication skills, ability to follow instructions and attention to details, perform sample forecast, retrieve and compile data from appropriate database.
Scope and level of responsibility increases with increasing level
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an outstanding work environment:
Business Week magazine 50 Best Places to Launch a Career
Black Enterprise 2018 list of 50 Best Companies for Diversity
FORTUNE 50 Best Companies for Minorities
Human Right Campaign Corporate Equality Index - 100% score
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.
Eli Lilly And Company