Advisor/Sr. Advisor – Peptide Analytical Scientist Full-time

Lilly 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 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 small molecule space.

Provides technical support and performs analytical development work for peptide synthesis/Process development lab; process development through design and execution of experiments and development of analytical methods.

This role expects to work in lab along with fellow scientists.

Key Responsibilities:

• Safety culture lab management: To ensure that appropriate personal protective equipment in the laboratory premises are available and follows the safety precautions. Ensure the good administration and housekeeping of the PRD department work area.

• Scientific & Technical Leadership: Work in the lab along with the team, provide analytical support to commercial process optimization team, in peptides down and up streams. Leverage internal and external expertise to improve existing production processes Establish a world class methodology to ensure analytical methods and techniques are robust, cost effective and can be transitioned safely and rapidly into production environment. Lead the successful transfer of new/developed analytical methods across the globe Maintain a thorough understanding of the state of the art of analytical and regulatory requirements and build these into our processes Develop strong working relationships with both R&D and plant sites to ensure success Serves as a member of multidisciplinary product development teams responsible for the analytical method for commercial scale processes. He/she typically directs the laboratory activities and development of one or more junior staff members Participate in the Science Lead Team– part of scientific governance/oversight as needed Provide technical stewardship on all products they are accountable for. Define and lead assigned technical projects (experimental, modelling, and/or production data analysis) to improve process control, yield, purity, and/or productivity. The Advisor/Senior advisor should also have a proven track record in the following areas.

• Demonstrated ability to commercialize and solve analytical problems.
• Hands on experience supporting method development and transfer activities
• Proven track record of working with diverse groups across the value chain and in multiple locations
• Significant experience with registration, including authoring technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies.

• Understanding the scientific principles(analytical front) 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.
• Proven record of embracing advanced digitization efforts by deploying digital tools to enable advanced modelling and seamless digital technology transfer
• Exhibit coaching and mentoring of peers and other scientists.
• Understand instrumentation including LC, GC, titration, and mass spectrometry and expertise in PAT tools
• Provide technical support to process development areas if needed
• Participate in technology transfer of analytical methods
• Document all work in an appropriate manner

In carrying out his/her responsibilities, the individual is expected to work very closely with fellow scientists across the various disciplines and build up a network of contacts across the corporation and the broader scientific community. He/she must have the interpersonal skills required to work effectively with a broad spectrum of people.

Education Requirement: Ph.D. in scientific disciplines of Chemistry and Analytical chemistry /Ph.D + Post Doc in Analytical Chemistry (focusing more process chemistry) with 5-12 years

Other Information: Some travel (domestic and international) less than 5% may be required.