Lilly Research Scientist in Indianapolis, Indiana
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.
Are you looking for a role working with top scientists using groundbreaking, state of the art technology? Do you wish to grow your career as a Formulations Scientist for biotherapeutics? If the answer is yes, then this could be the right role for you!
As a Formulation Scientist/Chemist/Engineer 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, Active Pharmaceutical Ingredient (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
Independently lead project, 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 fashion.
Authorship of technical reports and regulatory documents.
Present data at deep dive, formulation and/or other technical forums.
Familiarity of CT and commercial platform processes, working knowledge of CMO operations, as appropriate.
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.
Collaborate 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.
Support organizational initiatives, as required.
Partner effectively with external organizations 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 a plan and attention to details, perform sample forecast, retrieve and compile data from appropriate database.
Post-doctoral or additional relevant industry experience; 2 to 4 years experience in pharma or biotech company is highly desirable
Experience/ knowledge of parenteral formulations development for clinical and commercial use (including lyophilized and solutions formulations).
In depth understanding of protein chemistry, structure and conformation, as relates to chemical and physical stability.
Knowledge of biophysical techniques which are used to assess protein conformation (including secondary, tertiary, quaternary structure) and ability to apply these techniques for characterization and problem-solving during protein process and formulations development
Able to independently contribute from the bench (design and execute studies to develop a formulation)
Must be able to work productively in an interdisciplinary team environment
Good oral and written communication skills
Knowledge of process engineering first principles related to parenteral manufacturing
Experience with third party/ contract organizations
Experience with the drug development process including knowledge of regulatory compliance issues and fundamental knowledge of cGMP/ GMP compliance requirements
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
Travel: 10-15% but up to 30% of time within US and OUS.
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.
- PhD in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Biophysical Characterization, Chemical Engineering or related field with research focus on formulation related issues with monoclonal antibodies, proteins, peptides, or injectables
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.
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