Senior Advisor Peptide Process Development

Eli Lilly and Company; Telangana; On-site; INR 4,000,000 - 5,600,000; Full time

Job summary

Eli Lilly and Company is seeking a senior scientist for the Manufacturing and Quality Technical Hub Hyderabad to lead technical aspects of peptide drug-substance manufacturing. You will drive process optimization, technology transfer, and the development of the technical agenda with a focus on GMP compliance and cross-functional collaboration.

The role requires a PhD in Biochemistry or Chemistry with extensive post-PhD experience in peptide chemistry, and the ability to work with global

Qualifications

• Experience with GMP in pharmaceutical manufacturing.
• Knowledge of regulatory requirements and industry standards.
• Strong communication and leadership to manage internal/external stakeholders.

Responsibilities

• Oversee peptides and manufacturing processes, drive technical agenda.
• Lead post-launch technical programs and improve manufacturing performance.
• Ensure compliance, validated state, and robust documentation of processes/products.

Skills

GMP

Regulatory

Communication

Coaching

Documentation

Process oversight

Education

PhD in Biochemistry

PhD in Chemistry

Job description

Job Description:

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’re looking for people who are determined to make life better for people around the world.

Company Overview

Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges.

About Manufacturing And Quality Technical Hub Hyderabad

Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub. This hub will oversee the significant investment in contract manufacturing of starting materials and intermediates for API manufacturing in India and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of process engineering, chemistry, analytical and data sciences to build a cutting-edge scientific organization supporting the exciting manufacturing portfolio of Lilly.

Job Description

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 influence externally in the peptide space.

Basic Requirements

• Provide technical oversight and stewardship for peptides and manufacturing processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Proven experience at 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 that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Maintaining peptide processes in a state of compliance with US and global regulations.
• Understanding the scientific principles required for manufacturing intermediate 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 scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields, or equivalent industry experience.
• PhD + Post Doc in Chemistry (focusing more 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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

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.

Requirements: