Research Scientist-Formulation DevelopmentEli Lilly and Company - Indianapolis, IN
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.
Do you wish for a role working with top scientists using groundbreaking, state of the art technology? Are you looking to grow your career as a Formulations Scientist for biotherapeutics? If your answer is yes, then this could be the right role for you!
As a Research Scientist-Formulation Development, you are responsible for conducting and/or leading scientists involved in preformulation, formulation of parenteral and novel delivery systems, commercial development studies, and technology transfer to manufacturing sites for biomolecule projects. You will lead, support organization initiatives, bring new capabilities & technologies, and providing internal / external influence. Additional responsibilities might include:
Design of parenteral formulations to support development of clinical formulations (lyophilized and solution) and commercial drug product. Provide support for successful manufacture of clinical supplies.
Design and conduct commercial process development studies for drug product using expertise of scale-down/scale-up principles in one or more of the key unit operations in parenteral manufacturing; Support the transfer of drug product process to MS&T laboratories and pilot plant/manufacturing sites.
Collaborate with analytical and biophysical scientists to characterize the physicochemical properties of biomolecules by using orthogonal techniques
Collaborate effectively with the Bioprocess organization in the definition of the API matrix and in the development of the formulated bulk.
Collaborate with toxicology and clinical scientists and conduct supporting in-use / compatibility studies.
Collaborate with Discovery scientists to assess the “Developability” of biomolecules in support of candidate selection.
Author technical reports and regulatory documents
Align work and team activities with all relevant Development Quality, Regulatory, and HSE requirements.
Lead others in the design, execution and interpretation of experiments to drive the definition and optimization of formulations
Mentoring, training, and administration of performance management to personnel (primarily, but not limited to, direct reports)
PhD in Pharmaceutics or Pharmaceutical Sciences or Biochemistry or Biophysical Characterization or Chemical Engineering or related discipline
Understanding of lyophilized and solution formulations development, and parenteral manufacturing and drug delivery technologies.
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)
Post-doctoral or additional relate industry experience; 2 to 4 years of experience in pharma or biotech company.
Experience/ knowledge of parenteral formulations development for clinical and commercial use (including lyophilized and solutions formulations).
Deep 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
Some experience with mRNA delivery with emulision and lipid nanoparticle (LPN) technology and characterization.
Proven technical / scientific leadership skills; applied to problem-solving
Good oral and written communication skills
Ability to work productively in an interdisciplinary team environment
Experience with third party/ contract organizations
Experience with the drug development process, regulatory compliance issues, and cGMP/ GMP compliance requirements
Supervision of direct reports
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.
6 days 20 hours ago
Please review all application instructions before applying.
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.
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