Senior/Advisor - Formulation Scientist
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-72993
Organization Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, USA, with a mission to make life better for people around the world. With over 39,000 employees globally, Lilly focuses on discovering and delivering life-changing medicines, improving disease management, and giving back to communities.
The Product Research and Development (PRD) organization develops and delivers quality medicines, including insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies, and gene therapy systems. The PRD team collaborates with therapeutic business units and manufacturing to bring Lilly’s clinical portfolio to patients worldwide.
The Lilly Capability Centre India (LCCI) in Bengaluru is a strategic investment that leverages India’s vibrant academic and professional talent to develop and enable critical capabilities for Lilly. The LCCI PRD team closely collaborates with the PRD team in Indianapolis to support Lilly’s portfolio delivery.
Job Description & Responsibilities:
Solid Drug Product Manufacturing and Process Development:
Apply experience in solid drug product manufacturing unit operations to accelerate product development and enhance manufacturability.
Build comprehensive material and manufacturing process risk assessments to support formulation selection, development, and experimental work-plans.
Product Design and Quality Assurance:
Improve and develop product design by defining drug product critical quality attributes (CQAs).
Drive the implementation of new platforms such as continuous manufacturing, process analytical technologies (PAT), and modeling/simulation tools.
Design robust and globally acceptable manufacturing process control strategies.
Partner with manufacturing teams to transfer control strategies effectively.
Development and Project Management:
Lead short and long-term development activities, including prioritization of technical agendas and timelines.
Collaborate with cross-functional teams such as Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to execute clinical trials and regulatory submissions.
Regulatory Strategy and Compliance:
Lead the development of regulatory strategies, including authorship of INDs, NDAs, and responses to regulatory inquiries.
Ensure compliance with regulatory guidelines and internal policies.
Innovation and Problem-Solving:
Apply fundamental knowledge/experience in biopharmaceutics to solve novel problem statements and accelerate drug product development.
Embrace diverse thought, backgrounds, and experiences to deliver creative solutions that address unmet technical needs.
Engage with and influence the external environment by adopting external innovations to enhance Lilly’s drug product portfolio.
Minimum Qualifications:
Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or a related field with 4-7 years of experience.
Alternatively, B.S. or M.S. with 10+ years of equivalent demonstrated experience in a related field.
Experience in developing solid drug product formulations, manufacturing processes, and technical transfer of processes into manufacturing with a focus on complex combination products.
Additional Skills/Preferences:
Experience with new platforms such as PAT, modeling, and simulation tools.
Awareness of non-standard oral drug delivery technologies (e.g., modified release, peptides).
Knowledge and experience with managing technical projects.
Demonstrated leadership capabilities in team environments, including supervising or guiding the work of others.
Additional Information:
Position: LCCI
Travel: Some travel required.
Lilly’s Commitment:
Lilly is dedicated to providing equal opportunities for individuals with disabilities and ensuring full engagement in the workforce. If you require accommodation to submit a resume for a position, please complete the accommodation request form at Lilly Accommodation Request.
Lilly is an equal opportunity employer.
#WeAreLilly
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