Senior Manager, Extractables & Leachables
On-siteWoodbury, Minnesota, United States
Job Summary
Lead and develop a multidisciplinary team of analytical chemists to oversee extractables and leachables programs, chemical characterization, and component clearance for inhalation, transdermal, injectable, and drug-device combination products. Establish technical approaches for testing strategies, method development, and lifecycle management using techniques including GC-MS, LC-MS, and high-resolution mass spectrometry. Serve as a regulatory subject matter expert ensuring alignment with USP <1663>, USP <1664>, ISO 10993, and PQRI recommendations while partnering with Manufacturing, Quality, and Regulatory Affairs teams. Drive operational excellence initiatives to improve laboratory efficiency, throughput, and service levels across global supply chain activities.
Required Qualifications
- Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
- Minimum 10 years of analytical chemistry experience within pharmaceutical, medical device, combination product, or regulated healthcare industries
- Minimum 5 years of leadership experience managing scientific or laboratory teams
- Demonstrated expertise in extractables and leachables, chemical characterization, trace-level analytical testing, impurity analysis, or related disciplines
- Extensive experience with chromatographic and mass spectrometry techniques including GC-MS and LC-MS platforms
- Strong understanding of cGMP laboratory operations and quality systems
- Experience supporting regulated product development, commercial manufacturing, and supply chain activities
- Proven experience working within cross-functional organizations
- Strong technical writing, data interpretation, and communication skills
- Strong statistical knowledge, data trending capabilities, and experience establishing analytical specifications
- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
- USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
- ISO 10993-18 Chemical Characterization of Medical Device Materials
- ISO 10993-17 Toxicological Risk Assessment of Medical Device Constituents
- ISO 10993-12 Sample Preparation and Extraction Methods
- PQRI recommendations for orally inhaled and nasal drug products (OINDP)
- Nitrosamine guidance and emerging contaminant requirements
- Applicable FDA, EMA, USP, EP, and international regulatory expectations
Desired Qualifications
- Master's degree or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Toxicology, or related scientific discipline
- Direct experience leading extractables and leachables programs for pharmaceutical packaging, inhalation products, medical devices, or combination products
- Experience with inhalation, transdermal, injectable, and drug-device combination products
- Expertise in PQRI-based E&L programs and inhalation regulatory strategies
- Familiarity with toxicological risk assessment methodologies and interpretation of E&L data
- Experience supporting regulatory submissions and direct interactions with health authorities
- High-resolution mass spectrometry and unknown identification expertise
- Lean, Six Sigma Black Belt, or equivalent continuous improvement certification
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