Research Scientist-Crystallization/Particle Design
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.
Lilly’s Small Molecule Design and Development (SMDD) organization is involved in key development activities for small molecules and medium synthetic peptide active pharmaceutical ingredients from pre-clinical phases through commercialization for drug substances and drug products. Our scientists develop key technical and business solutions across the portfolio using their deep technical expertise to speed testing of the clinical hypothesis and overall drug development. SMDD tackles this diversity of responsibilities by recognizing an even greater diversity of talents and cultures is necessary to deliver the next generation of life changing medicines to patients. Innovation and integration is at the heart of what SMDD does. Our new state of the art research facilities are even designed to promote it!
Lilly is seeking outstanding candidates to work at the drug substance - drug product interface for pharmaceutical development in a Particle design and crystallization process development role. The position presents an opportunity to work side by side with process development teams to deliver key information deliverables needed to advance drug development while enabling the next generation of product design by developing new technical solutions across the portfolio. The position will be based in Indianapolis where research is conducted in a new, state of the art development facility which enables collaboration and innovation (opened in June 2018). At Lilly, innovation is a key differentiator and this next generation of product development is crucial to speed the delivery of life-changing medicines to patients.
The Particle Design Laboratory (PDL) resides within Small Molecule Design and Development (SMDD) and serves as a core competency center for particle and crystallization process design. The responsibilities and opportunities for this role include:
Define the physical properties of the API required for the drug product and design crystallization processes in order to fulfill the physical property and chemical purity requirements, and support process scale-up and technology transfer.
Leverage / develop process analytical technology, continuous processing, mechanistic models and novel formulation platforms to develop well understood and robust processes capable of enhancing or tailor API physical properties.
In addition to small molecule API’s, work on new peptide crystallization and precipitation platforms and lead our development in this area.
Provide leadership within teams: Serve as a member of integrated commercial team (ICT) responsible for the development and demonstration of new bulk chemical processes. Provide key process information to the larger CMC team enabling the team to devise physical property and impurity control strategies. Direct and mentor technicians and younger scientists to deliver the portfolio and capability projects.
Publish original research externally, author internal technical documents and control strategies for new product registration applications.
Engage in a highly collaborative work environment across the crystallization, material science, analytical and formulation development areas including collaboration with external academic researchers.
Control API properties through a firm understanding of thermodynamics and kinetics and scale variables such as heat and mass transfer to deliver the desired crystal form, chemical purity, and physical properties.
Design and execute laboratory experimentation in support of crystallization process design using manual and automated high and low throughput reactors and leverage models to support process development.
PhD in Chemical Engineering, Materials Science or related discipline or BS/MS with 7+ years of industry experience.
Utilization of chemical engineering fundamentals towards process design: understanding of heat and mass transfer, thermodynamics, crystallization and precipitation kinetics, solid-liquid separations, drying, particle size reduction techniques (milling), experimental design, mixing theory.
Experience with modeling, especially utilization of solubility and process models (including population balance models) along with the use of models for optimization and risk assessment.
Experience with materials science, formulation development, absorption modeling, and modeling how physical properties impact drug product performance and / or manufacturability (both mechanistic or multivariate data analysis).
Experience with online and offline analytical techniques and PAT such as HPLC, GC, NMR, IR, Raman, FBRM and solid state characterization techniques such as XRPD, DSC, TGA, particle size and microscopy to guide process development.
Scale-up experience of multiple products and or platforms with demonstrated understanding of scale-dependency. Knowledge of GMP quality systems.
Good oral communication and documentation skills.
Teamwork/Interpersonal skills and experience leading teams and formulating business strategies.
Experience with data interpretation, including the application of chemometrics, multivariate modeling, or other data analysis tools.
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