Senior Director - Analytical Development and Quality ...

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. Weu2019re looking for people who are determined to make life better for people around the world. The Avid groupu2019s mission is to discover, develop, and deliver diagnostic solutions that improve global health by accelerating the development of new medicines. Avidu2019s diagnostic solutions aid in early diagnosis, monitor the treatment effect of therapeutics and help understand disease pathology better. Avid is leveraging the power of diagnostics to transform patient outcomes. Avid is committed to accelerating the next generation of diagnostic tools to understand and unlock the potential of emerging science, enables the discovery of new medicines, and advance care for patients with unmet needs. Position Summary: The Senior Director, Analytical Development and Quality Control (AD/QC), is responsible for overseeing the analytical development and quality control functions for the diagnostic radiopharmaceutical products and associated radiopharmaceutical precursors and reference standards. This position serves as the lead to drive AD/QC strategies and deliverables and ensure key business goals are met. Additionally, this position provides strategic leadership for the AD/QC organization by defining longu2011term departmental vision, aligning analytical and QC strategies with broader CMC and corporate objectives, and ensuring the organization maintains scientific, operational, and compliance excellence. This position is accountable for building and developing a highu2011performing team through proactive coaching, structured mentoring, performance management, careeru2011path development, and workforce planning to ensure the group is equipped to meet current and future business needs. Responsibilities: Strategic Technical Leadership u00b7 Provide advice and guidance to senior management for best practice in AD/QC strategies and methodologies. u00b7 Develop and execute longu2011term strategic plans for analytical development and QC that anticipate evolving regulatory, portfolio, and technology needs. u00b7 Drive adoption of advanced analytical technologies and operational best practices to enhance scientific rigor, method robustness, and QC reliability. u00b7 Identify risks to current and proposed AD/QC strategies and establish mitigation strategies to address those risks. u00b7 Identify problems and challenges with deliverables and establish effective solutions in a timely manner to minimize disruption to project milestones. u00b7 Champion a culture of scientific innovation by proactively identifying, evaluating, and implementing emerging analytical technologies to enhance the sensitivity, specificity, and efficiency of analytical methods and quality control processes u00b7 Establish and nurture external collaborations with academic institutions, technology providers, and industry consortia to stay at the forefront of analytical science and quality control innovation. u00b7 Drive internal innovation initiatives, including pilot projects, proof-of-concept studies, and technology scouting, to continuously improve analytical capabilities and operational excellence. u00b7 Foster an environment that encourages creative problem-solving, calculated risk-taking, and the sharing of new ideas across the AD/QC organization Team Leadership, Coaching & Employee Development u00b7 Develop, motivate, and retain a highu2011performing AD/QC team through structured goalu2011setting, continuous coaching, targeted capability development, and active mentoring of scientific and managerial staff. u00b7 Implement talentu2011review processes, succession planning, and individualized development plans to build longu2011term organizational capability. u00b7 Promote a culture of accountability, innovation, scientific excellence, and continuous improvement. u00b7 Ensure onboarding, training, and competency frameworks are fully implemented and periodically refreshed. Crossu2011Functional Leadership u00b7 Serve as team leader for crossu2011functional teams to effectively drive business goals. u00b7 Represent AD/QC in executiveu2011level strategic planning, portfolio reviews, crossu2011functional governance forums, and regulatory interactions. u00b7 Ensure alignment and effective communication between AD/QC, other CMC cross functional areas including CMC, manufacturing, supply chain, regulatory, QA, and other internal/external partners. Operational & Resource Management u00b7 Direct the efforts of the AD/QC team, optimize resources to meet key project milestones, and report progress to management. u00b7 Lead departmental budgeting, capital planning, and resource allocation to support laboratory operations, instrumentation strategy, and staffing. u00b7 Establish and monitor departmental KPIs, operational metrics, and quality indicators to drive performance and compliance. Analytical Development and Quality Control Leadership u00b7 Direct the development of analytical methods suitable for internal and external implementation. u00b7 Direct the validation of analytical methods to applicable global standards. u00b7 Champion continuous improvement initiatives that strengthen method lifecycle management, documentation practices, and analytical robustness. u00b7 Author and/or review CMC documents pertinent to analytical development and quality control for regulatory submissions. u00b7 Direct analytical method technology transfer to CMOs. u00b7 Direct internal QC activities for commercial products and clinical trial materials. u00b7 Direct, delegate, and assure compliance of QC activities. u00b7 Manage release testing of precursors and reference standards. u00b7 Direct the release of clinical trial materials/components manufactured at Avid. u00b7 Maintain effective QCu2011related cGMP documents. u00b7 Maintain oversight of precursor and reference standard CMO QC activities. u00b7 Build and maintain an organizational structure that supports current operations and anticipated growth, ensuring appropriate staffing, competencies, and succession coverage. u00b7 Maintain currency with applicable global cGMP regulations and industry standards. Basic Requirements : u00b7 PhD degree or equivalent in chemistry or a related field with at least 15 years of experience in industrial pharmaceutical analytical development/QC and at least 10 yearsu2019 experience in QC management. u00b7 Thorough knowledge of cGMPs, ICH Quality guidance, and FDA CMC guidance. u00b7 Thorough knowledge of industry standard pharmaceutical QC methods and validation procedures. Additional Preferences: u00b7 Strong project management and organizational skills. u00b7 Proven ability to think strategically. u00b7 Demonstrated leadership and relationship building including cross functional teamwork and ability to interact with senior management. u00b7 Ability to manage multiple and competing priorities through effective organizational, people, and time management skills. u00b7 Excellent written and verbal communication skills. u00b7 Significant experience leading scientific teams, coaching scientific staff, and developing leadership talent. u00b7 Familiarity with radiochemistry desirable but not required. u00b7 Ability to travel internationally as needed. Additional Information/Travel: _The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job._ Work Environment: This positionu2019s work environment is in an Office setting. _The_ _work_ _environment_ _characteristics_ _described_ _here_ _are_ _representative of those an employee encounters while performing the essential functions of this job._ 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 ( ) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Womenu2019s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidateu2019s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lillyu2019s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Created: 2026-03-07