Senior/ Advisor – Peptide Process Development

Eli Lilly and Company; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

A leading pharmaceutical company in Hyderabad seeks a technical leader for its Manufacturing and Quality Hub. The role involves directing drug substance manufacturing, coordinating technical resolutions, and ensuring compliance with regulatory standards. Applicants should have a PhD or equivalent in related fields, with extensive experience in peptide chemistry. Strong communication skills and project management capabilities are crucial for success in this position.

Qualifications

• Proven track record of driving technical agendas in peptide manufacturing.
• Experience leading technical resolutions related to control strategy and manufacturing.
• Ability to maintain compliance with US and global regulations.

Responsibilities

• Lead technical aspects of drug substance manufacturing including process optimization.
• Manage communication with internal and external stakeholders.
• Ensure proper documentation of all processes and specifications.

Skills

Technical oversight for peptides

Good Manufacturing Practices (GMP)

Project management

Excellent communication skills

Education

PhD in Biochemistry, Chemistry, Chemical Engineering or related fields

Post Doctoral experience focusing on Peptide chemistry

Job description

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. Our employees work to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek people determined to make life better for others.

Company Overview

Lilly is a leading innovation-driven company developing a growing portfolio of pharmaceutical products by applying the latest research from its worldwide laboratories and collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better through medicines and information for urgent medical needs. Founded over 145 years ago, the company values excellence, integrity and respect for people. Lilly looks to its employees as the drivers of innovation and impact, and invites you to join our team to make a difference in improving health worldwide.

About Manufacturing And Quality Technical Hub Hyderabad

Lilly has invested over $1B to establish a Manufacturing and Quality technical hub. The hub will oversee contract manufacturing of starting materials and intermediates for API manufacturing in India and manage the scientific agenda for manufacturing and quality. It will recruit top talent in process engineering, chemistry, analytical and data sciences to build a cutting-edge organization supporting Lilly’s manufacturing portfolio.

Role Overview And Key Responsibilities

• The employee leads technical aspects of drug substance manufacturing including process optimization, technical transfers and development of the technical agenda.
• This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.
• The successful candidate should have a proven track record of driving technical agendas and influencing externally in the peptide space.

Basic Requirements

• Provide technical oversight and stewardship for peptides and manufacturing processes.
• Lead resolution of technical issues including those related to control strategy and manufacturing.
• Proven experience leading post-launch technical agendas and delivering projects that have driven substantial step changes in manufacturing (specific to M&Q and may not be required for development).
• Employ excellent communication skills to manage internal and external relationships.
• Manage project work through active coaching and delegation of junior scientists and engineers.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Maintain peptide processes in a state of compliance with US and global regulations.
• Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Understand the chemistry and stability of peptides from a first principles perspective.

Education Requirement

• PhD in Biochemistry, Chemistry, Chemical Engineering, or related fields, or equivalent industry experience.
• PhD + Post Doctoral experience in Chemistry focusing on Peptide chemistry with 12+ years.

Other Information

• Some travel (domestic and international) less than 5% may be required.

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 at https://careers.lilly.com/us/en/workplace-accommodation for further assistance. This is for individuals to request an accommodation as part of the application process; 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.

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