Senior Director - Analytical Development and Quality Control

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.

The Avid group’s mission is to discover, develop, and deliver diagnostic solutions that improve global health by accelerating the development of new medicines. Avid’s 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 long‑term 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 high‑performing team through proactive coaching, structured mentoring, performance management, career‑path development, and workforce planning to ensure the group is equipped to meet current and future business needs.

 

Responsibilities:

Strategic Technical Leadership

·         Provide advice and guidance to senior management for best practice in AD/QC strategies and methodologies.

·         Develop and execute long‑term strategic plans for analytical development and QC that anticipate evolving regulatory, portfolio, and technology needs.

·         Drive adoption of advanced analytical technologies and operational best practices to enhance scientific rigor, method robustness, and QC reliability.

·         Identify risks to current and proposed AD/QC strategies and establish mitigation strategies to address those risks.

·         Identify problems and challenges with deliverables and establish effective solutions in a timely manner to minimize disruption to project milestones.

·         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

·         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.

·         Drive internal innovation initiatives, including pilot projects, proof-of-concept studies, and technology scouting, to continuously improve analytical capabilities and operational excellence.

·         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

·         Develop, motivate, and retain a high‑performing AD/QC team through structured goal‑setting, continuous coaching, targeted capability development, and active mentoring of scientific and managerial staff.

·         Implement talent‑review processes, succession planning, and individualized development plans to build long‑term organizational capability.

·         Promote a culture of accountability, innovation, scientific excellence, and continuous improvement.

·         Ensure onboarding, training, and competency frameworks are fully implemented and periodically refreshed.

Cross‑Functional Leadership

·         Serve as team leader for cross‑functional teams to effectively drive business goals.

·         Represent AD/QC in executive‑level strategic planning, portfolio reviews, cross‑functional governance forums, and regulatory interactions.

·         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

·         Direct the efforts of the AD/QC team, optimize resources to meet key project milestones, and report progress to management.

·         Lead departmental budgeting, capital planning, and resource allocation to support laboratory operations, instrumentation strategy, and staffing.

·         Establish and monitor departmental KPIs, operational metrics, and quality indicators to drive performance and compliance.

Analytical Development and Quality Control Leadership

·         Direct the development of analytical methods suitable for internal and external implementation.

·         Direct the validation of analytical methods to applicable global standards.

·         Champion continuous improvement initiatives that strengthen method lifecycle management, documentation practices, and analytical robustness.

·         Author and/or review CMC documents pertinent to analytical development and quality control for regulatory submissions.

·         Direct analytical method technology transfer to CMOs.

·         Direct internal QC activities for commercial products and clinical trial materials.

·         Direct, delegate, and assure compliance of QC activities.

·         Manage release testing of precursors and reference standards.

·         Direct the release of clinical trial materials/components manufactured at Avid.

·         Maintain effective QC‑related cGMP documents.

·         Maintain oversight of precursor and reference standard CMO QC activities.

·         Build and maintain an organizational structure that supports current operations and anticipated growth, ensuring appropriate staffing, competencies, and succession coverage.

·         Maintain currency with applicable global cGMP regulations and industry standards.

 

 

Basic Requirements:

·         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 years’ experience in QC management.

·         Thorough knowledge of cGMPs, ICH Quality guidance, and FDA CMC guidance.

·         Thorough knowledge of industry standard pharmaceutical QC methods and validation procedures.

 

Additional Preferences:

·         Strong project management and organizational skills.

·         Proven ability to think strategically.

·         Demonstrated leadership and relationship building including cross functional teamwork and ability to interact with senior management.

·         Ability to manage multiple and competing priorities through effective organizational, people, and time management skills.

·         Excellent written and verbal communication skills.

·         Significant experience leading scientific teams, coaching scientific staff, and developing leadership talent.

·         Familiarity with radiochemistry desirable but not required.

·         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 position’s 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 (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.

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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), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s 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 Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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