Senior Manager, Manufacturing Sciences & Technology (MSAT) – Drug Product (Packaging & Inspection)

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: The Senior Manager of Manufacturing Sciences & Technology (MSAT) – Drug Product leads the technical strategy and execution supporting sterile drug product packaging, assembly, labeling, serialization/aggregation, and final product inspection (manual, semi-automated, and automated) for commercial and clinical products. This role owns process robustness across the product lifecycle—from technology transfer and Process Performance Qualification (PPQ) through commercial Continuous Process Verification (CPV)—and provides on-the-floor technical oversight to ensure current Good Manufacturing Practice (cGMP) compliance, right-first-time execution, inspection accuracy, and product quality. The role partners closely with Manufacturing, Quality, Validation, Supply Chain, Engineering, Automation/Information Technology (IT), and Regulatory functions.

Responsibilities:
Technical Leadership & Strategy
• Provide technical stewardship for sterile drug product packaging and inspection processes across the product lifecycle, including line setup and qualification, format changeover strategies, parameter control, and maintenance of Control Strategies, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs).
• Lead technology transfers (site-to-site and line-to-line), including process fit assessments, gap analyses, User Requirements Specifications (URS), functional specifications for inspection and packaging equipment, and readiness activities supporting Process Performance Qualification (PPQ) and commercialization.
• Champion process robustness and error-proofing strategies across manual and automated operations, including recipe management, validated vision system algorithms and settings, and alarm management strategies.

Inspection & Packaging Excellence (Sterile)
• Oversee manual, semi-automated, and automated visual inspection programs, including defect libraries, Acceptable Quality Level (AQL) and sampling plans, operator qualification, challenge sets, lighting and contrast standards, camera configuration, and sensitivity settings.
• Own the Container Closure Integrity (CCI) strategy and testing methods (e.g., dye ingress, High Voltage Leak Detection (HVLD), vacuum decay), ensuring alignment with USP <1207> and visual inspection best practices per USP <1790>.
• Ensure compliant sterile assembly, labeling, serialization and aggregation (GS1 standards), tamper-evident features, and artwork and Unique Device Identification (UDI) control, partnering with Automation and IT on Level 4/Level 5 interfaces and data reconciliation.
• Drive packaging and inspection line performance by reducing false reject rates, optimizing Overall Equipment Effectiveness (OEE), and addressing chronic micro-stops and reject trends.

Deviation Management, CAPA, Change Control & QMS
• Lead complex technical investigations related to packaging and inspection deviations, complaints, and stability events using structured root cause methodologies (e.g., 5-Why, Fishbone, Fault Tree Analysis, DMAIC).
• Author, review, and approve Change Controls for equipment, materials, methods, and process parameters, including risk assessments aligned with ICH Q9 and Annex 1 contamination control principles, as applicable to sterile operations.
• Ensure timely and effective implementation and verification of Corrective and Preventive Actions (CAPAs), and support audit responses, regulatory inspections, and associated commitments.

Validation & Digital Systems
• Lead teams and own the selection, implementation, and qualification of inspection, assembly, and packaging equipment.
• Sponsor and review validation deliverables including URS, Functional Specifications (FS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), PPQ protocols and reports, cleaning validation (where applicable), and Continued Process Verification (CPV) plans with robust statistical monitoring.
• Partner with Automation and IT to ensure compliant deployment and integration of Manufacturing Execution Systems (MES), electronic batch records, Laboratory Information Management Systems (LIMS), serialization systems, and vision systems, maintaining data integrity in accordance with ALCOA+ principles and 21 CFR Part 11.
• Champion data analytics and visualization to support trend detection and decision-making, including false reject segmentation, misclassification heatmaps, process capability indices (Cpk/Ppk), and CPV dashboards.

Lifecycle, Supplier & Material Stewardship
• Maintain product technical files, historical process knowledge, and annual product reviews through