Eli Lilly and Company

Research Scientist-Pharmaceutical Product Development

Location
Indianapolis, IN, United States
Posted
Nov 03, 2018
Ref
43481
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 are looking for people who are determined to make life better for people around the world.

Responsibilities
Do you seek an opportunity to lead highly technical drug product development projects while working closely with clinical, quality, regulatory, manufacturing, and other development teams? Do you have strong technical problem solving ability and an internal motivation to achieve quality results in a fast-paced environment? If so, we have a role for you!
Small Molecule Design and Development (SMDD) is comprised of diverse groups that design and execute the development of all CMC aspects of small molecules from pre-clinical phases through commercialization for drug substances and drug products. With a goal of enabling next generation research and development, we seek to develop and explore new technical solutions across our portfolio. This work will focus on the integration of early clinical and commercialization activities including clinical study and drug product design, formulation development, and global regulatory submission support.

You will leverage a strong background in pharmaceutical sciences, biopharmaceutics, and clinical design to fulfill responsibilities in drug product development which include:
  • Partnering with groups throughout development, manufacturing, clinical, quality, and regulatory to plan and manage short/long term development activities aligned with the global CMC strategy.
  • Integrating fundamental pharmaceutical sciences knowledge (formulation, biopharmaceutics, pharmacokinetics) and patient centered aspects into the design of new small molecule dosage forms and development processes.
  • Building and leveraging internal and external networks to solve complex technical problems and to identify and implement novel formulations, manufacturing technologies, and clinical study designs that enhance internal capabilities and processes.
  • Collaborating and communicating project specific challenges and opportunities with key partners within the company and in the external network.
  • Authoring and reviewing high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions
43481BR

Basic Qualifications
Ph.D. in pharmaceutical sciences, material science, biomedical engineering or other related disciplines.

Additional Skills/Preferences
  • Knowledgeable and experienced in clinical study design.
  • Deep understanding of biopharmaceutics/pharmacokinetic principles, and drug product/process design factors impacting in vivo performance of drug products.
  • Fundamental understanding of material science and impact on drug product manufacturing and performance.
  • Basic understanding of analytical aspects of drug product design and testing.
  • Knowledgeable in drug delivery options/systems.
  • Basic understanding of regulatory aspects pertaining to development and clinical testing of drug products.


Additional Information
  • Limited travel may be required
  • 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