Eli Lilly and Company · 4 hours ago
Director-Analytical Development and QC
Philadelphia, PA
Full-time
Onsite
Director/Executive
$144K/yr - $211K/yr
10+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Director of Analytical Development and Quality Control is responsible for managing the development and validation of analytical methods for radiopharmaceutical imaging agents, ensuring compliance with regulations and overseeing the AD/QC team.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Manage 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
Manage 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
Manage day-to-day operations of AD/QC labs and AD/QC team and ensure compliance with cGMP regulations, SOPs and HSE procedures. Ensure readiness of AD/QC labs for inspections by regulatory agencies, quality assurance and HSE
Develop, motivate, and retain high-performing team by providing relevant performance goals, delegating appropriately, empowering team members to take initiative, and coaching team members in their development
Lead decision-making and problem-solving processes within the team
Maintain proficiency with applicable and current global cGMP regulations and industry standards and trends
Qualification
Required
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
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-02-06
2026-02-06
Company data provided by crunchbase