Director/Sr Director/Executive Director Central TSMS for Small Molecule API

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

Job Description

Join the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Team that delivers a diverse portfolio of drug substances essential to Lilly! Here in Lilly, we have an exciting pipeline of Small Molecule products that require critical expertise to ensure robust operating control strategies and manufacturing focused scientific capability.   The Central API TSMS Director/Executive Director will serve as Manufacturing TSMS senior representative to work with Small Molecule API Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new small molecule APIs.  The successful candidate will provide technical and scientific expertise supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the small molecule portfolio.  The Director will oversee technical aspects of the development of API manufacturing, including technical depth of understanding of unit operations,  technical transfers and process validation strategy.  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.

Key Objectives/Deliverables:

• Leverage prior experience to anticipate commercial manufacturing challenges for new small molecule/synthetic active pharmaceutical ingredients (APIs). Work across the Development organization and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.    
• Establish strong working relationships with Lilly’s Small Molecule development organization to assess the portfolio assets as they progress through development/commercialization milestones and provide informed feedback on synthetic routes and process conditions to influence ultimate manufacturing processes.
• Establish depth of understanding of control strategy (CS) of molecules and translate this control strategy into unit operation requirements to ensure robust and right first time technology transfer to commercial facilities.
• Have a depth of understanding of the analytical control strategy that allows critical technical review of the implementation of the analytical CS , including process analytical technology for on line and at line monitoring and control.  Understand all critical quality attributes and any analytical method challenges leading to variability that is separate from process variability.
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Provide technical leadership for technology transfers between Development and manufacturing sites (