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Open nowPosted 71 days ago

Senior Manager, Extractables & Leachables

kindeva78 open roles

Where
Woodbury, MN, USA
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Your applicationOpen nowSenior Manager, Extractables & Leachableskindeva · Woodbury, MN, USA

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This job: posted 71 days ago

The posting

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make Kindeva Drug Delivery is seeking an experienced Manager, Chemical Characterization, Extractables & Leachables to lead a multidisciplinary analytical organization supporting pharmaceutical, combination product, and medical device programs. This role provides scientific, operational, and people leadership for teams responsible for chemical characterization, method development, extractables and leachables (E&L) assessments, trace-level analytical testing, and component clearance activities supporting Kindeva's inhalation, transdermal, injectable, and drug-device combination product portfolios. The successful candidate will serve as a technical and regulatory subject matter expert in E&L and chemical characterization programs, ensuring testing strategies align with current regulatory expectations, business objectives, and product development requirements. This individual will oversee both advanced analytical development activities and routine testing operations while partnering closely with Manufacturing, Quality, Regulatory Affairs, Toxicology, Supply Chain, and Product Development teams. The position requires recognized expertise in applying USP <1663>, USP <1664>, ISO 10993 chemical characterization requirements, PQRI recommendations for inhalation products, and toxicological risk assessment principles to develop scientifically sound and regulatory-compliant extractables and leachables strategies. We are seeking a proven leader who can translate complex regulatory requirements into practical laboratory strategies while maintaining high scientific standards and operational excellence. Responsibilities Leadership & Organizational Management

Lead and develop a team of analytical chemists and laboratory professionals supporting chemical characterization, extractables and leachables testing, trace impurity analysis, and component clearance programs. Provide coaching, mentoring, performance management, succession planning, and career development for scientific staff. Establish priorities and allocate resources across multiple commercial, development, and compliance-driven programs. Foster a culture of scientific excellence, collaboration, accountability, and continuous improvement. Develop departmental goals, metrics, and capacity plans aligned with organizational objectives.

Scientific & Technical Leadership

Provide technical oversight for extractables and leachables programs supporting inhalation products, transdermal systems, injectables, medical devices, packaging systems, and drug-device combination products. Designing technical approach for testing and instrumentation and presenting to clients, assisting in building of quotes and helping manage projects as the E&L Leader. Lead development, qualification, validation, transfer, and lifecycle management of analytical methods. Oversee chemical characterization studies utilizing techniques such as:

GC-MS GC-MS/MS LC-MS LC-MS/MS High-resolution mass spectrometry (HRMS) ICP-MS Chromatographic and spectroscopic techniques

Guide investigations involving unknown compound identification, contamination events, atypical results, and complex analytical challenges. Support structural elucidation and non-targeted analytical evaluations. Drive implementation of new analytical technologies and laboratory capabilities.

Component Clearance & Quality Operations

Lead analytical programs responsible for qualification and clearance of plastic, elastomeric, and other critical components used in drug delivery systems. Partner with global manufacturing sites to ensure efficient testing, qualification, and release of critical materials throughout the supply chain. Ensure timely execution of routine and complex analytical testing to support development and commercial manufacturing requirements. Provide technical oversight for reference standards management and related analytical support activities. Drive improvements in laboratory efficiency, throughput, and service levels.

Regulatory & Compliance Leadership

Serve as a subject matter expert in global regulatory expectations for extractables, leachables, and chemical characterization programs. Maintain expertise in:

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

Partner with Toxicology and Regulatory Affairs teams to establish:

Analytical Evaluation Thresholds (AET) Reporting thresholds Identification thresholds Qualification thresholds Toxicological risk assessments

Support product submissions, technical justifications, regulatory inspections, and customer audits. Help define analytical and regulatory strategies for inhalation combination products, container closure systems, and medical devices.

Cross-Functional Collaboration

Collaborate effectively with Manufacturing, Product Development, Quality Assurance, Regulatory Affairs, Toxicology, Supply Chain, Procurement, Project Management, and Commercial teams. Serve as a technical interface with customers, suppliers, external laboratories, auditors, and regulatory agencies. Communicate complex scientific information clearly to both technical and executive audiences. Support strategic decision-making through strong scientific and risk-based assessments.

Continuous Improvement

Drive operational excellence initiatives focused on laboratory efficiency, capacity, quality, and cost effectiveness. Implement continuous improvement programs utilizing Lean, Six Sigma, or other improvement methodologies. Identify opportunities to streamline testing processes and accelerate component clearance timelines. Monitor industry trends and emerging regulatory expectations to ensure proactive capability development.

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.

Preferred 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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