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Pharmaceutical
Organization Overview:u00A0
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.u00A0u00A0
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 Lillyu2019s portfolio.u00A0
u00A0Job description & Responsibilitiesu00A0
Apply experience in solid drug product manufacturing unit operations to accelerate product development of combination products and improve manufacturability.u00A0
Build comprehensive material and manufacturing process risk assessments to aid formulationselection, development, and experimental work-plans.u00A0
Improve and develop product design through definition of drug product critical quality attributes (CQAs).u00A0
Drive the implementation of new platforms such as continuous manufacturing, process analytical technologies (PAT), and modeling and simulation tools.u00A0
Design robust and globally acceptable manufacturing process control strategies as well as partner with manufacturing teams to transfer those control strategies.u00A0
Lead short and long-term development activities including prioritization of technical agendas and timelines.u00A0
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.u00A0
Lead the development of regulatory strategies including authorship of INDs, NDAs, and response to regulatory inquiries.u00A0
Demonstrate agility to apply fundamental knowledge/experiencein biopharmaceutics to novel problem statements in order to accelerate drug product development.u00A0
Embrace diverse thought, background, and experience to deliver creative solutions that address unmet technical needs.u00A0
Engage and influence the external environment as well as demonstrate the ability to recognize and adopt external innovation across Lillyu2019s drug product portfolio.u00A0
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Minimum Qualifications:u00A0
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 expertiseu00A0
Experience with developing solid drug product formulations, manufacturing processes and technical transfer of processes into manufacturing with emphasis on complex combination products.u00A0u00A0
Additional Skills/Preferences:u00A0
Experience in new platforms such as PAT, Modelling and simulation tools.u00A0
Awareness of non-standard (e.g. modified release, peptide) oral drug delivery landscapeu00A0u00A0
Knowledge and experience with management of a technical projectu00A0
Demonstrated leadership capabilities in a team environment and supervising or guiding the work of othersu00A0
Additional Information:u00A0
Position: LCCIu00A0
Some travel necessaryu00A0
Lilly 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 () 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.
Lillyu00A0does 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.
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Date Posted: 16/10/2024
Job ID: 96512075
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\u2019re looking for people who are determined to make life better for people around the world. 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. \u00A0
