Principal Scientist, Formulations, BR&D

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 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:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in Oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles, Antibody Drug Conjugates and AAV and other non-viral vector delivery.

We are seeking a highly motivated Scientist with an interest or experience in developing parenteral drug product through various stages of clinical development. If you are interested in building platforms for new and novel therapeutic modalities and interested in building and leading a strong group of scientists exploring new frontiers into formulation and drug delivery strategies, you should consider joining our diverse team.

Responsibilities:

• 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 manner.
• Authorship of technical reports and regulatory document (IND/CTA, BLA/NDA).
• 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.
• Work effectively with Analytical Development in the definition of Drug Product physical and chemical stability properties as well as coordination of analytical testing support.
• 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.
• Work effectively with external partners on outsourcing efforts and research collaborations.
• Good laboratory skills and familiarity with formulation, analytical/biophysical techniques and methods capability and hands-on experience with laboratory instruments
• Good communication skills, ability to follow instructions and attention to details, perform sample forecast, retrieve and compile data from appropriate database.

Basic Requirements:

• Master’s degree with 2-5 years of industry experience, or a bachelor’s degree with 5+ years of industry experience in pharmaceutical science, chemistry, biochemistry or related field.

Additional Preferences:

• Background knowledge of parenteral formulation development and understanding of stability issues associated with parenteral drug product (e.g. proteins, peptides or genomic medicines) are highly desirable.
• Basic computer skills. Advanced computer skills (e.g. computational modeling, database creation, analysis tool creation, and statistics) are highly desired.<