Advisor/ Sr. Advisor \u2013 Small Molecule process development

Company Overviewu00A0

Lilly, a leading innovation-drivenu00A0corporation,u00A0is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.u00A0u00A0Headquartered in Indianapolis, Indiana, Lilly makes life better u2013 through medicines and information u2013 for some of the worldu2019s most urgent medical needs.u00A0u00A0Founded over 145 years ago, the company has sustained a culture that values excellence,u00A0integrity,u00A0and respect for people. This has resulted in Lillyu00A0frequentlyu00A0being ranked as one of the best companies in the world at which to work.u00A0u00A0Lilly knows its business has prospered because of its employees u2013 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.u00A0 Join our team u2013 and make a difference in improving health for people all over the world!u00A0

Manufacturing and Quality Technical Hub Hyderabadu00A0

Lilly has made a strategic investment of more than $1B dollars tou00A0establishu00A0a 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.u00A0u00A0

Job Descriptionu00A0

Role Overviewu00A0and Key Responsibilities:u00A0

The employee leads technical aspects of drug substance process optimization, technicalu00A0transfersu00A0and development of the technical agenda.u202F 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 provenu00A0track recordu00A0of driving technical agendas and influence externally in theu00A0small moleculeu00A0space.u00A0

Key Responsibilities:u00A0

Work in the ab along with the teamu00A0towardsu00A0process development of manufacturing processesu00A0

Leverage internal and externalu00A0expertiseu00A0to improve existing production processesu00A0

Establish a world classu00A0methodologyu00A0to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into productionu00A0

Lead the successful transfer ofu00A0new processesu00A0or steps into production across the globeu00A0

Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into our processesu00A0

Develop strong working relationships with both R&D and plant sites to ensure successu00A0

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 membersu00A0

Participateu00A0in theu00A0Science Lead Teamu2013 part of scientific governance/oversight as neededu00A0

Provide technical stewardship on all products they are accountable for.u00A0

Define andu00A0lead assignedu00A0technical projects (experimental,u00A0modelling,u00A0and/or production data analysis) to improve process control, yield,u00A0purity,u00A0and/or productivity.u00A0u00A0u00A0

Theu00A0Advisor/Senioru00A0advisoru00A0should also have a provenu00A0track recordu00A0in the following areas.u00A0

• Demonstrated ability to commercialize and solve manufacturing problems.u00A0

• Hands on experience supporting production at different scales from both a commercialization and supply perspective.u00A0

• Provenu00A0track recordu00A0of working with diverse groups across the value chain and in multiple locationsu00A0u00A0

• Understanding the interaction of bulk drug substance and drug product formulation-interaction of equipment set(s) with process (drug substance and drug product)u00A0

• Significant experienceu00A0with registration, includingu00A0authoringu00A0technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies.u00A0

u00A0

Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.u00A0

• Understand the chemistry and stability of peptides from a first principles perspective.u00A0

• Proven record of embracing advanced digitization efforts by deploying digital tools to enableu00A0advanced modellingu00A0and seamless digital technology transferu00A0

• Exhibit coaching and mentoring of peers and other scientists.u00A0
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In carrying out his/her responsibilities, theu00A0individualu00A0is 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 skillsu00A0requiredu00A0to work effectively with a broad spectrum of people.u00A0

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Education Requirement:u00A0

• Ph.D. inu00A0scientificu00A0disciplines ofu00A0Organicu00A0Chemistry/Chemistry withu00A0Ph.D/Post Doc in Chemistry (focusing moreu00A0processu00A0chemistry)u00A0withu00A05-u00A012 yearsu00A0u00A0

Other Information:u00A0

• Some travel (domestic and international) less than 5% may beu00A0required.u00A0