Senior Manager, Extractables & Leachables

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeKindeva 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 Kindevas inhalation transdermal injectable and drug-device combination product 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 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 are seeking a proven leader who can translate complex regulatory requirements into practical laboratory strategies while maintaining high scientific standards and operational & Organizational ManagementLead and develop a team of analytical chemists and laboratory professionals supporting chemical characterization extractables and leachables testing trace impurity analysis and component clearance coaching mentoring performance management succession planning and career development for scientific priorities and allocate resources across multiple commercial development and compliance-driven a culture of scientific excellence collaboration accountability and continuous departmental goals metrics and capacity plans aligned with organizational & Technical LeadershipProvide technical oversight for extractables and leachables programs supporting inhalation products transdermal systems injectables medical devices packaging systems and drug-device combination technical approach for testing and instrumentation and presenting to clients assisting in building of quotes and helping manage projects as the E&L development qualification validation transfer and lifecycle management of analytical chemical characterization studies utilizing techniques such as:GC-MSGC-MS/MSLC-MSLC-MS/MSHigh-resolution mass spectrometry (HRMS)ICP-MSChromatographic and spectroscopic techniquesGuide investigations involving unknown compound identification contamination events atypical results and complex analytical structural elucidation and non-targeted analytical implementation of new analytical technologies and laboratory Clearance & Quality OperationsLead analytical programs responsible for qualification and clearance of plastic elastomeric and other critical components used in drug delivery with global manufacturing sites to ensure efficient testing qualification and release of critical materials throughout the supply timely execution of routine and complex analytical testing to support development and commercial manufacturing technical oversight for reference standards management and related analytical support improvements in laboratory efficiency throughput and service & Compliance LeadershipServe as a subject matter expert in global regulatory expectations for extractables leachables and chemical characterization expertise in:USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery SystemsUSP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery SystemsISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 10993-17 Toxicological Risk Assessment of Medical Device ConstituentsISO 10993-12 Sample Preparation and Extraction MethodsPQRI recommendations for orally inhaled and nasal drug products (OINDP)Nitrosamine guidance and emerging contaminant requirementsApplicable FDA EMA USP EP and international regulatory expectationsPartner with Toxicology and Regulatory Affairs teams to establish:Analytical Evaluation Thresholds (AET)Reporting thresholdsIdentification thresholdsQualification thresholdsToxicological risk assessmentsSupport product submissions technical justifications regulatory inspections and customer define analytical and regulatory strategies for inhalation combination products container closure systems and medical -Functional CollaborationCollaborate effectively with Manufacturing Product Development Quality Assurance Regulatory Affairs Toxicology Supply Chain Procurement Project Management and Commercial as a technical interface with customers suppliers external laboratories auditors and regulatory complex scientific information clearly to both technical and executive strategic decision-making through strong scientific and risk-based ImprovementDrive operational excellence initiatives focused on laboratory efficiency capacity quality and cost continuous improvement programs utilizing Lean Six Sigma or other improvement opportunities to streamline testing processes and accelerate component clearance industry trends and emerging regulatory expectations to ensure proactive capability degree in Chemistry Analytical Chemistry Pharmaceutical Sciences Chemical Engineering or related scientific 10 years of analytical chemistry experience within pharmaceutical medical device combination product or regulated healthcare 5 years of leadership experience managing scientific or laboratory expertise in extractables and leachables chemical characterization trace-level analytical testing impurity analysis or related experience with chromatographic and mass spectrometry techniques including GC-MS and LC-MS understanding of cGMP laboratory operations and quality supporting regulated product development commercial manufacturing and supply chain experience working within cross-functional technical writing data interpretation and communication statistical knowledge data trending capabilities and experience establishing analytical QualificationsMasters degree or PhD in Chemistry Analytical Chemistry Pharmaceutical Sciences Toxicology or related scientific experience leading extractables and leachables programs for pharmaceutical packaging inhalation products medical devices or combination with inhalation transdermal injectable and drug-device combination in PQRI-based E&L programs and inhalation regulatory with toxicological risk assessment methodologies and interpretation of E&L supporting regulatory submissions and direct interactions with health -resolution mass spectrometry and unknown identification Six Sigma Black Belt or equivalent continuous improvement certification.#LI-Onsite