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

Kindeva Drug Delivery•Bridgeton, MO

14d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.