Developing analytical methods and conducting experiments to aid early clinical formulation development to enable drug delivery of a broad range of synthetic drug molecules.
Collaborating with formulation scientists to design experiments and guide selection and characterization of formulations for pre-clinical and early clinical drug candidates.
Partnering with biopharmaceutical modeling scientists, analytical chemists, pharmaceutical scientists, and engineers to identify the appropriate drug form, formulation, and process characteristics that provide the desired drug product performance.
Identifying and mitigating technical risks for the performance and production of clinical and commercial drug products.
Executing with attention to safety, quality, regulatory, GLP/GMP, and legal requirements for all activities.
Authoring key regulatory documents, demonstrating appropriate understanding of product performance control strategy, and biopharmaceutics risk mitigation for clinical trials and product commercialization.
Embrace diverse thought, background, and experience to deliver innovative solutions.
Possess strong communication (oral, written), organizational, and leadership skills.
Engaging and influencing the external scientific community to foster collaborations for innovation and to advance Lilly's internal portfolio.
Basic Requirements:
B.S. in Chemistry, Biochemistry, Pharmaceutical Science, or other directly related discipline (e.g., Material Science)
Understanding of analytical techniques and methods for characterizing physicochemical properties of drug molecules and performance of drug products (e.g., HPLC, UV, NIR, dissolution)
Strong leadership, supervisor, teamwork, communication and writing skills.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/Preferences:
Industry, research or internship experience relevant to the position is strongly preferred.
Knowledge of biopharmaceutics and pharmacokinetic principles, formulation development and pharmaceutical material sciences, and drug product factors impacting in vivo performance and manufacture.
Basic understanding of regulatory aspects pertaining to development and clinical testing of drug products.
General understanding of techniques and instrumentation used in characterization of pharmaceutical drug products, especially dissolution and other product performance tests.
Other Information:
This position will be on our LTC-N Campus in Indianapolis, IN
Travel: 0-10%
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Benefits
Health insurance
Additional Information
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.
Organization and Position Overview:
At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.
Candidates should have hands-on experience in analytical chemistry and/or pharmaceutical sciences, including exposure to techniques such as spectroscopy, chromatography, formulation development, or biopharmaceutics. They should be motivated to continue building their skills and deepen their understanding of molecular properties, product and process design, and product performance in order to support drug product development from early research through commercialization.
Eli Lilly · Indianapolis IN