Eli Lilly and Company

Research Scientist-Formulations

Location
Indianapolis, IN, United States
Posted
Oct 26, 2018
Ref
44535
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're looking for people who are determined to make life better for people around the world.

Responsibilities
Due to a strategic commitment to the growth of biotherapeutics within the Lilly portfolio, opportunities are currently available within the Bioproduct Research and Development organization. This group is a multidisciplinary organization, focused on the development and commercialization of monoclonal antibodies, novel therapeutic proteins and peptides. These efforts are maximized through the collaborative activities of scientists at our Indianapolis sites with partners in discovery and manufacturing, taking full advantage of our scientific excellence and engineering capabilities in drug substance, analytical and drug product / device development, coupled with the integrated operational strategy of the biotherapeutic discovery, development and manufacturing organizations. If you are interested in being considered for employment with a "Best in Class" Pharmaceutical company, please review the following opportunity

As a scientist in this organization, you will be responsible for conducting and/or leading scientists involved in conducting preformulation, design of stable parenteral formulations for use with novel delivery systems, commercial development studies and technology transfer to manufacturing sites for assigned biomolecule projects including peptides, proteins and monoclonal antibodies. You will work collaboratively with a wide array of scientists and engineers from many disciplines, leading / supporting organization initiatives, bringing new capabilities / technologies and providing internal / external influence.

The responsibilities for this role will include:
  • Design and perform studies to characterize molecular properties of monoclonal antibodies, proteins and peptides under clinical development
  • Design of parenteral biologic formulations using preformulation principles to support development of clinical formulations (lyophilized and solution) and commercial drug product.
  • Collaborate with external partners and academic institutions on development of nanoparticulate based drug delivery systems.
  • Collaborate with process engineers to design and conduct commercial process development studies for drug product by using expertise/knowledge of scale-down/scale-up principles
  • Collaborate with process engineers to provide support for successful technology transfer for manufacture of clinical supplies.
  • Authoring of technical reports and regulatory documents
  • Keep abreast of relevant new technologies / capabilities and regulatory expectations / requirements
  • Management of formulation development activities for a drug candidate ranging from timelines, project planning and coordination of studies with other groups
  • Ability to coach, train and lead others in the design, execution and interpretation of experiments to drive the definition and optimization of formulations
  • Ensure work and team activities are aligned with all relevant Development Quality, regulatory and HSE requirements.
44535BR

Basic Qualifications
  • 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


Additional Skills/Preferences
  • Experience/ knowledge of lyophilized and solution formulations development, and parenteral manufacturing
  • Basic understanding of proteins, degradation pathways, and general approaches for stabilization
  • 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
  • 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.
  • Prior experience in development and characterization of lipid based nanoparticulate delivery systems
  • Understanding of the fundamental of Gene Therapy, Cell Therapy and Vaccine Development
  • 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
  • Demonstrated technical / scientific leadership skills; applied to problem-solving
  • 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
  • Some experience with supervision of direct reports


Additional Information
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.

Lilly earns consistent and wide recognition for creating an exceptional work environment:
  • Business Week magazine 50 Best Places To Launch A Career™
  • FORTUNE America's Most Admired Companies™
  • FORTUNE 50 Best Companies for Minorities™
  • Working Mother 100 Best Companies for Working Mothers™
  • Industry Week magazine 100 Best-Managed Companies™
  • Business Ethics magazine 100 Best Corporate Citizens™
  • Science magazine Best Companies for Scientists™

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