Job Title: Senior/Advisor - Formulation Scientist
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-72993
About Eli Lilly and Company:
At Eli 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 across the world work to discover and bring life-changing medicines to those in need, improve disease management, and give back to communities through philanthropy and volunteerism. We're looking for people who are determined to make life better for people everywhere.
The Product Research and Development (PRD) team strives to develop and deliver quality medicines to patients. The PRD portfolio includes the development and commercialization of insulins, small molecules, monoclonal antibodies, therapeutic proteins, peptides, oligonucleotide therapies, and gene therapy systems. The Lilly Capability Centre India (LCCI), located in Bengaluru, is key to Lilly's global success, housing a team that collaborates with Lilly's PRD team in Indianapolis to enable the delivery of Lilly’s clinical portfolio.
Key Responsibilities:
Formulation & Process Development:
Apply experience in solid drug product manufacturing to accelerate product development, especially for combination products.
Conduct risk assessments for material and manufacturing processes to aid formulation selection and development.
Define critical quality attributes (CQAs) for drug products and contribute to their design.
Drive the use of innovative platforms such as continuous manufacturing, process analytical technologies (PAT), and simulation tools.
Manufacturing & Control Strategies:
Develop globally acceptable manufacturing process control strategies and partner with manufacturing teams for their implementation.
Lead short and long-term development activities, including technical agenda and timeline prioritization.
Collaboration & Regulatory Strategy:
Collaborate with cross-functional teams (Product Delivery, Project Management, Quality, Manufacturing, Regulatory) to deliver materials and information for clinical trials and regulatory submissions.
Lead the development of regulatory strategies, including authorship of INDs, NDAs, and responses to regulatory inquiries.
External Engagement & Innovation:
Apply fundamental knowledge in biopharmaceutics to solve novel problems and accelerate drug development.
Engage with the external environment to adopt innovative solutions 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./M.S. with 10+ years of relevant experience.
Demonstrated experience in developing solid drug product formulations, manufacturing processes, and technical transfer of complex combination products.
Experience with PAT, modeling and simulation tools.
Awareness of modified release, peptide oral drug delivery landscapes.
Proven leadership capabilities in managing technical projects and guiding team efforts.
Additional Information:
Position: Based at the Lilly Capability Centre India (LCCI) in Bangalore.
Some travel may be necessary.
Equal Opportunity Employer:
Lilly is committed to providing equal employment opportunities to all individuals, including those with disabilities. If you need assistance during the application process, please visit Workplace Accommodation for support. Lilly does not discriminate on the basis of age, race, religion, gender, sexual orientation, disability, or other legally protected statuses.
How to Apply:
Interested candidates can apply directly through Lilly's career portal.
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