الوصف الوظيفي
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 Overview: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, USA. Our 39,000 employees worldwide 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.The Product Research and Development (PRD) organization) strives to develop and deliver quality medicines to patients. The portfolio consists of development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world. The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a PRD team that works closely with the PRDteam in Indianapolis in enabling the delivery of Lilly’s portfolio.Job description & ResponsibilitiesApply experience in solid drug product manufacturing unit operations to accelerate product development of combination products and improve manufacturability.Build comprehensive material and manufacturing process risk assessments to aid formulationselection, development, and experimental work-plans.Improve and develop product design through definition of drug product critical quality attributes (CQAs).Drive the implementation of new platforms such as continuous manufacturing, process analytical technologies (PAT), and modeling and simulation tools.Design robust and globally acceptable manufacturing process control strategies as well as partner with manufacturing teams to transfer those control strategies.Lead short and long-term development activities including prioritization of technical agendas and timelines.Partner with multi-functional teams such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute and deliver material and information for clinical trials and regulatory submissions.Lead the development of regulatory strategies including authorship of INDs, NDAs, and response to regulatory inquiries.Demonstrate agility to apply fundamental knowledge/experiencein biopharmaceutics to novel problem statements in order to accelerate drug product development.Embrace diverse thought, background, and experience to deliver creative solutions that address unmet technical needs.Engage and influence the external environment as well as demonstrate the ability to recognize and adopt external innovation across Lilly’s drug product portfolio.Minimum Qualifications:Ph.D. in chemical engineering, pharmaceutical sciences or a related field with 4-7 years of experience or B.S. or M.S. with 10+ years of demonstrated equivalent experience in a related field of expertiseExperience with developing solid drug product formulations, manufacturing processes and technical transfer of processes into manufacturing with emphasis on complex combination products. Additional Skills/Preferences:Experience in new platforms such as PAT, Modelling and simulation tools.Awareness of non-standard (e.g. modified release, peptide) oral drug delivery landscape Knowledge and experience with management of a technical projectDemonstrated leadership capabilities in a team environment and supervising or guiding the work of othersAdditional Information:Position: LCCISome travel necessaryLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly 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.#WeAreLilly
