Advisor/ Sr. Advisor – Small Molecule process development

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.  Join our team – and make a difference in improving health for people all over the world! 

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. 

Key Responsibilities: 

Work in the ab along with the team towards process development of manufacturing processes 

Leverage internal and external expertise to improve existing production processes 

Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production 

Lead the successful transfer of new processes or steps into production across the globe 

Maintain a thorough understanding of the state of the art of manufacturing 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 commercial scale development of new 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 manufacturing problems. 

• Hands on experience supporting production at different scales from both a commercialization and supply perspective. 

• Proven track record of working with diverse groups across the value chain and in multiple locations  

• Understanding the interaction of bulk drug substance and drug product formulation-interaction of equipment set(s) with process (drug substance and drug product) 

• Significant experience with registration, including authoring technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies. 

Understanding 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. 

• 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. 
   

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 Organic Chemistry/Chemistry with Ph.D/Post Doc in Chemistry (focusing more process chemistry) with 5- 12 years  

Other Information: 

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