Senior Manager, Extractables & Leachables

Manager, Chemical Characterization, Extractables & Leachables

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 , USP , 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.

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…