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.
The Synthetic Molecule Design and Development (SMDD) organization within Lilly is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical and business solutions to advance a dynamic portfolio that includes small molecules, peptides, oligonucleotides, and other emerging therapeutic modalities. By encouraging a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.
SMDD has an exciting opportunity for a Research Advisor to join our multidisciplinary team of chemists, engineers, and formulation scientists. Empowered by access to world-class capabilities and extensive pharmaceutical development experience, you will help deliver innovative technical solutions that enable deeper understanding of processes and products across the portfolio. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem-solving, and be motivated to work both independently and collaboratively in a dynamic environment.
Candidates must possess a strong background in analytical chemistry and/or pharmaceutical sciences. We have particular interest in candidates with understanding of spectroscopy, chromatography, formulation development, and biopharmaceutics and the ability to integrate this understanding with knowledge of molecular properties, product and process design, and product performance to develop drug products that enable pre-clinical programs through commercialization.
Position Responsibilities:
- Develop and apply drug product performance tests and models, such as biopredictive, biorelevant, and compendial dissolution, as well as in silico models of product performance and absorption to advance the development of new drug products.
- Partner with biopharmaceutics, analytical, pharmaceutical scientists, and engineers to identify the appropriate drug form, formulation, and process characteristics that provide the desired drug product performance.
- Network with ADME, PK/PD, and Clinical scientists to design pre-clinical and clinical studies to test hypotheses related to product performance.
- Identify and mitigate technical risks for the production and in vivo performance of clinical and commercial drug products, and establish robust control strategies through generation of data, development of analytical methods, and collaboration with internal and external development partners.
- Author regulatory documents, such as IND, biowaiver, BCS classification, and NDA/CTD submissions related to product performance.
- Engage with scientists across development and manufacturing to develop a deep understanding of new initiatives and improve existing scientific approaches related to drug product performance.
- Execute all activities in compliance with safety, quality, regulatory, GLP/GMP, and legal requirements.
- Embrace diverse thoughts, backgrounds, and experiences to deliver innovative pharmaceutics solutions through technical leadership, teamwork, and mentoring.
- Engage and influence the external scientific community to foster collaborations for innovation and to advance Lilly's internal portfolio.
- Demonstrate strong written and verbal communication skills to convey both technical and business-related implications of your work.
Basic Qualifications:
- Ph.D. in Analytical Chemistry or Pharmaceutical Science, or other related discipline (e.g., material science, physical chemistry, engineering), MS with 7+ years of relevant experience, or BS with 10+ years of relevant experience will also be considered.
- In depth understanding of analytical techniques and methods for characterizing physicochemical properties of drug molecules and performance of drug products (e.g., HPLC, UV, dissolution)
Additional Skills/Preferences:
- Experience with data interpretation, including the application of chemometrics, multivariate modeling, and other data analysis tools.
- Strong leadership, teamwork, communication and writing skills.
- Knowledge of biopharmaceutics, formulation development and pharmaceutical material sciences, and drug product attributes impacting in vivo performance and manufacture.
- Basic understanding of regulatory aspects pertaining to development, clinical testing, and approval of drug products.
- General understanding of techniques and instrumentation used in characterization of pharmaceutical drug products, especially dissolution and other product performance tests.
- Learning agility and demonstrated ability to apply technical knowledge to improve the understanding of chemical systems or improve analytical techniques.
- Ability to balance multiple activities, prioritize evolving project needs, and handle ambiguity.
Additional Information:
- Possible exposure to chemicals, allergens, and loud noises.
- Occasional travel (0-10%) may be required.
- Position Location: Indianapolis, IN.
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