Senior / Principal Scientist- Peptide

Overview

Lilly is hiring a Principal Technical Services Representative (API EM) for its Manufacturing and Quality Technical Hub in Hyderabad. The role provides technical leadership and oversight of peptide manufacturing processes at contract manufacturers, reporting to the TSMS Director – Peptides API EM.

What you'll do

• Develop and sustain process knowledge to ensure the appropriate product, process, and operational control strategy is executed at the Contract Manufacturer (CM).
• Interact directly and indirectly with CM personnel to ensure reliable supply through execution of the operational control strategy.
• Participate with internal or CM resources in technical transfer, process validation, and process data monitoring.
• Adhere to the expectations of the Lilly Red Book when interacting with API EM's CMs.
• Monitor processes, respond to issues, and drive improvements where necessary.
• Build and sustain Lilly / CM Joint Process Team relationships, providing insight and feedback from past unit operation control experience.
• Manage internal and external relationships, and build and maintain relationships with development and central technical organizations.
• Coach and mentor peers and other scientists.
• Provide technical oversight and stewardship for peptide manufacturing processes, ensuring they are compliant, capable, in control, and maintained in a validated or qualified state.
• Enable development and maintenance of process knowledge infrastructure, such as validated process monitoring spreadsheets.
• Review and track key process parameters (e.g., CPPs, rOPPs, IPC).
• Provide process support and lead resolution of technical issues, including those related to control strategy and manufacturing.
• Ensure proper characterization of processes and products, and effective documentation of process descriptions, measures, acceptable ranges, specifications, and their justification.
• Understand, justify, and document the state of validation with data evaluating process capability.
• Identify systemic issues affecting production and reliable supply from CMs; lead or participate in root cause analysis and CAPA development.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain peptide processes in compliance with US and global regulations.
• Apply scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Support development and technical analysis for continuous improvement activities.
• Identify cost reduction opportunities, process capacities, and bottlenecks; assist in prioritizing opportunities against business objectives.
• Perform and promote optimization of unit operation cycle time, loading, and yield performance.

What you'll need

• Bachelor of Science in Chemistry or Biochemistry.
• 5+ years of demonstrated experience and proficiency with GMP pharmaceutical manufacturing.
• Working knowledge of regulatory expectations.
• Demonstrated ability to function in a team environment as a technical leader and as a team member.
• Demonstrated ability to manage and prioritize competing priorities and communicate verbally and in writing to various audiences.
• Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards.
• A strong understanding of manufacturing principles and Lilly systems.

Nice to have

• Successful application of root cause analysis and systematic problem solving.
• Knowledge and experience with regulatory requirements.
• Knowledge of data management practices across manufacturing.
• Enthusiasm for change, team spirit, and flexibility.
• Ability to influence and communicate to diverse groups on business or technical issues within the site and function.
• Proficiency in delivering complex and cross-functional tasks.
• Demonstrated project management skills and ability to coordinate complex projects.

Details

• Location: Hyderabad, India.
• Normal schedule is Monday–Friday, 8 hours/day; teleconferences may routinely occur outside these hours due to contract manufacturer time zones.
• Tasks require entering manufacturing and laboratory areas and wearing appropriate PPE.
• Some travel is required.