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 throughout the product lifecycle.
• Collaborate with Procurement and Quality to support supplier qualification, incoming material controls (e.g., vials, stoppers, seals, labels, cartons), and monitoring of material-related defect trends.
• Evaluate and implement continuous improvement initiatives such as optimized format parts, enhanced vision algorithms, lighting kits, robotics/cobots, auto-reject mechanisms, and changeover reduction initiatives (SMED).

People Leadership & Ways of Working

• Build, lead, and develop a high-performing MSAT team by setting clear objectives, coaching performance, and supporting career development.
• Promote a safety-first culture and strong GMP discipline through active shop-floor and Gemba engagement.
• Standardize and continuously improve SOPs, batch record instructions, inspection and packaging work instructions, and training programs.
• Serve as a key site technical leader during regulatory inspections and customer audits.

Basic Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, Packaging), Pharmaceutical Sciences, or related technical field.
• Minimum of 8 years of experience in pharmaceutical or biotechnology manufacturing with direct experience in sterile packaging, assembly, and visual inspection for drug products.
• Proven leadership of cross-functional teams and delivery of technology transfer, PPQ/validation, and CPV in a cGMP environment.

Preferred Qualifications:

• Advanced degree (Master’s or Doctorate) in a relevant field.
• Experience with sterile drug product operations including vials, syringes, or cartridges, Annex 1 contamination control considerations, and aseptic behaviors.
• Hands-on experience with automated inspection systems, CCI methods, and serialization/aggregation using GS1 standards.
• Proficiency with MES, LIMS, TrackWise (or equivalent Quality Management Systems), SAP/Enterprise Resource Planning (ERP), and data analytics tools.
• Strong working knowledge of 21 CFR Parts 210, 211, and 11; European Union Good Manufacturing Practices (EU GMPs); ICH Q8, Q9, and Q10; USP <1207>; USP <1790>; and ANSI/ASQ Z1.4 sampling standards.

Working Conditions

• On-site role with substantial shop-floor presence supporting multiple shifts.
• May require off-shift or weekend support during investigations, PPQ, or critical manufacturing campaigns.
• Ability to be present in classified areas and support sterile packaging operations, including standing and walking during line support and inspections.
• Travel approximately 10–20% to equipment vendors, partner sites, or sister facilities.

# LI-Onsite

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