Executive Director

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 (internal or external).
Ensure proper characterization of intermediate and API 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).
Manage internal and external relationships in cases where manufacturing facilities are managed by the External Manufacturing teams as well as providing additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. 
Lead resolution of technical issues including those related to control strategy and operational challenges.
Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. 
Work closely with Development and Global Regulatory teams to author/review regulatory submission documents and subsequently respond to Information Requests/Regulatory Questions.
Ensure that processes are compliant, capable, in control, and maintained in a validated state.
Successfully deliver on functional strategic initiatives.
Influence and implement the network technical agenda and drive continuous improvement.
Build and maintain relationships with central technical organizations to allow for development of innovative solutions, be it technology or process design, that will require cross functional support for development and implementation.
Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of raw materials, processes, and product attributes to improve product/process robustness, reduce variability, and provide improvement or advanced application of control strategies across sites and technologies. 
Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. 
Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. 
Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. 
Achieve network level results for Lilly’s Small Molecule APIs that improve the impact and effectiveness of TS/MS and other parts of the business by supporting or driving key organizational knowledge and capability work. Influence global leadership to drive improvements and resolve issues.

Basic Requirements

MSc/Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields, or equivalent overall industry experience (10 years +).
Minimum 8 yrs manufacturing experience in Small Molecule.
Demonstrated proficiency with pharmaceutical manufacturing and strong working knowledge of regulatory expectations.
Proven experience at leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.