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.
Organization & Role Overview:
Eli Lilly and Company is dedicated to bringing innovation to patients and is growing its manufacturing operations significantly to meet the demand for our medicines. As a result, our Global Quality Analytical Sciences & QC Operations organization who is responsible for delivering the commercialization and lifecycle of analytical methods as well as innovative and standardized tools for the QC laboratories globally is also growing.
The Senior Director/Executive Director Analytical Chemistry is responsible for partnering with our development organization to establish and deliver the analytical control strategy for new molecules and to provide lifecycle support for commercial molecules globally. This individual will provide technical leadership and strategic direction across the growing pipeline of Lilly molecules. The successful candidate will support delivery of commercialization efforts including analytical method validations, technical transfers, and life cycle management and optimization for chemistry and biochemistry methods. This team covers all product modalities including small molecule, peptides, large molecules, combination and cell and gene therapy products. They require a deep technical understanding of the methodologies employed in the control strategy and will interact closely with analytical chemists and process chemists across development and manufacturing. This position requires comprehensive knowledge of the pharmaceutical industry, analytical chemistry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. Further this individual will be a key technical mentor for other scientists in the organization.
Key Objectives/Deliverables:
The Senior Director/Executive Director for Analytical Chemistry is responsible for:
Having a depth of understanding of the analytical control strategy that allows critical technical review of the implementation of the controls, including raw materials, in process methods, release methods, specifications, and process analytical technology applications. Understand all critical quality attributes and any analytical method challenges leading to variability that is separate from process variability.
Ensure that analytical methods are compliant, capable, in control, and maintained in a validated state.
Leveraging prior experience to anticipate commercial manufacturing challenges for analytical control strategies and methods. Work across the development organization and QC labs globally to implement new product control strategies and provide lifecycle support to commercial molecules.
Ensure proper characterization of molecules and ensure effective documentation and knowledge management for the analytical control strategy, specifications, and methodologies.
Provide technical leadership for technology transfers between Development and manufacturing sites (internal or external).
Establish in depth knowledge in the production processes and analytical control strategies supporting a variety of molecule platforms including small molecules, insulins, monoclonals, peptides, siRNA, and Cell/Gene Therapy.
Provide analytical technical support of QC laboratories globally. Including managing internal and external relationships. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles.
Provide technical leadership to analytical scientists supporting both molecule and platform stewardship. Developing consistent analytical stewardship models which encompass support for drug substance and drug product elements and span the complete Lilly portfolio.
Partner closely with other senior level analytical stewards globally to deliver on global priorities, ensure strong development of future technical talent,
Lead resolution of technical issues including those related to analytical control strategy and method execution challenges.
Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer or approver of technical reports, provide input on the experimental findings and conclusions.
Work collaboratively across different disciplines such as manufacturing sciences and quality assurance on technical projects, method 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.
Build and maintain relationships with cross functional organizations to allow for development of innovative solutions, be it technology or method design, that will require cross functional support for development and implementation.
Remain current on external pharmaceutical manufacturing analytical trends and innovations. Engage in the external environment to influence guidance, scientific advancement and regulation
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 the analytical sciences organization that improve the impact and effectiveness of the team, driving key organizational knowledge and capability work. Influence global leadership to drive improvements and resolve issues.
Minimum Requirements:
MSc/Ph.D. degree in Chemistry, Biochemistry, Microbiology or strongly related field.
Minimum of 10 years of experience in analytical chemistry within the pharmaceutical industry.
Additional Preferences:
Expertise in analytical techniques such as HPLC, GC, Mass Spec, Microbiology, Bioassay, and spectrophotometry
Extensive knowledge of GMP and other pharmaceutical industry regulations and standards.
Strong interpersonal skills and ability to communicate effectively across all levels
Extensive knowledge of QC methodologies, regulatory requirements, and industry best practices.
Proven experience in R&D Quality or Manufacturing Quality operations in pharma including method development, technical transfers, and QC operations.
Demonstrated technical leadership skills with the ability to manage and develop high-performing teams
Visionary individual who can drive innovation and operational excellence while maintaining the highest standards of quality and compliance.
Strong knowledge of FDA, EMA, and ICH regulations and USP, EP, JP, and CHP requirements.
Other Information:
This position requires travel to domestic and international destinations.
This position requires working in manufacturing environments where there may be specific dress code requirements.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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