Director-Analytical Development and QC

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.

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 35,000 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 Overview:

The Director, Analytical Development and Quality Control (AD/QC) will play a lead role in managing the development and validation of phase-appropriate methods for radiopharmaceutical imaging agents throughout the development phases. This position requires a strong technical background in analytical methods and compliance with CGMP regulations, ensuring the integrity of products from preclinical through commercialization of a product. This position will be responsible for coaching and mentoring other scientists to support their growth and development.

Key Responsibilities:

• Play a lead role in the development and validation of phase-appropriate (pre-clinical through commercial) analytical methods to applicable global standards that are suitable for internal and external (CRO / CMO) implementation for assay, purity and dissolution methodologies; compendial methods verification; identification of impurity and degradation products; reference standard qualification, and physical (solid-state) characterization
• Develop phase-appropriate specifications and quality control strategy for drug substance and drug product.
• Develop and manage phase-appropriate drug substance and drug product stability study programs and ensure retest and expirations dates can support clinical development and regulatory objectives & timelines
• Maintain oversight of precursor and reference standard AD/QC activities at CMOs including planning, coordinating, and management of routine testing and associated stability programs at CMOs
• Support analytical method technology transfer to CMOs
• Review / QC batch record analytical data packages
• Support troubleshooting analytical issues and OOS investigations with CRO/CDMO
• Manage and provide guidance on outsourced studies, timely receipt of quality test data and other relevant documentation, and preparation of final study reports
• Author and/or review analytical development, validation and stability reports and analytical sections in global regulatory dossiers and support responses to information requests from health authorities.
• Present project progress including critical needs/issues at project meetings
• Participate in initiatives for improving functional processes and technical operations within CMC
• Ensure compliance with cGMP regulations, SOPs and HSE procedures. Ensure readiness of AD/QC labs for inspections by regulatory agencies, quality assurance and HSE.
• Help to develop, motivate, and retain high-performing team by empowering team members to take initiative, and coaching team members in their development
• Play a lead role in decision-making and problem-solving processes within the team
• Maintain proficiency with applicable and current global cGMP regulations and industry standards and trends

Required Experience and Skills:

• A BS degree in chemistry or a related field with at least 15 years of experience in industrial pharmaceutical analytical development/QC or an advanced degree with 10+ years of experience
• 10 years’ experience in lab management
• Demonstrated advanced understanding of cGMPs, ICH Quality guidance, FDA CMC guidance
• Demonstrated ability to communicate complex issues accurately and succinctly, both horizontally and vertically across the development organization

Preferred Skills/Experiences:

• PhD in analytical chemistry 
• Excellent scientific knowledge in analytical chemistry and experience with using traditional and advanced analytical techniques, including but not limited to HPLC, UPLC, TLC, GC, LC-MS, GC-MS, FTIR, UV, NMR, XRPD
• Familiarity with sterility, microbiological and endotoxin testing
• Familiarity with radiochemistry and radiopharmaceutical products is desirable but not required
• Strong project management and organizational skills

• Proven ability to think strategically
• Demonstrated leadership and relationship building including cross-functional teamwork skills 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
• Ability to travel domestically and internationally as needed

Location:

Onsite in Philadelphia

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 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), 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

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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