Manager, Packaging Operations

Kindeva Drug Delivery•St. Louis, MO

21h•Onsite

About The Position

The Operations Packaging Manager is directly responsible for the safe, compliant, and efficient execution of packaging operations for parenteral drug products and combination products within a contract development and manufacturing organization (CDMO) environment at Kindeva’s Maryland Heights location. This role provides leadership and oversight for packaging operations supporting auto-injector assembly, labeling, cartoning, and final packaging, as well as packaging operations for vials, cartridges, and prefilled syringe products intended for commercial and clinical distribution. The Packaging Manager is responsible for leading a unionized manufacturing workforce and front-line supervisors to ensure all packaging activities are executed in compliance with current Good Manufacturing Practices (cGMP), internal quality systems, customer requirements, and domestic and international regulatory requirements. The role is accountable for delivering production plans safely, efficiently, and on schedule while meeting quality, labor, and material utilization targets.

Requirements

Bachelor’s degree in a relevant technical field or scientific field
7+ years of manufacturing experience in pharmaceutical, biotech, medical device, or combination product manufacturing environments.
Demonstrated knowledge of current Good Manufacturing Practices (cGMP), data integrity requirements, and applicable domestic and international regulatory requirements governing pharmaceutical and combination product manufacturing.
Proven leadership experience in manufacturing environments, including development of supervisors and frontline personnel; union manufacturing experience preferred.
Strong leadership, communication, organizational, and problem-solving skills with the ability to manage multiple priorities, drive accountability, and effectively interact with customers, regulators, and all levels of the organization.
Demonstrated ability to analyze production data and operational metrics to drive performance, troubleshoot issues, and support continuous improvement initiatives.

Nice To Haves

Experience supporting automated packaging systems, labeling, cartoning, serialization, packaging line integration, equipment implementation, qualification, startup, and technology transfer activities preferred.
Proven ability to drive operational excellence, continuous improvement, and cross-functional collaboration in a fast-paced Contract Development and Manufacturing Organization (CDMO) environment.

Responsibilities

Lead and own all packaging operations for sterile injectable and combination products, serving as Subject Matter Expert during audits and regulatory inspections.
Ensure all packaging operations are executed in compliance with cGMP requirements, data integrity standards, internal procedures, and customer and regulatory requirements.
Partner with Quality and Regulatory teams to support audits, inspections, investigations, deviations, CAPAs, and change control activities.
Build and lead a high-performance team by coaching and developing supervisors and unionized personnel, establishing clear expectations, and driving accountability for safety, quality, compliance, productivity, and operational objectives.
Ensure packaging operations are appropriately staffed and scheduled to meet production demands while partnering with Inspection and upstream operations to maintain coordinated product flow and minimize disruptions.
Drive continuous improvement using operational excellence and structured problem-solving to enhance reliability, efficiency, and throughput.
Partner cross-functionally with Engineering, Validation, Maintenance, and Technical Services to support implementation, qualification, optimization, and performance of packaging systems.
Support new customer onboarding, technology transfers, and implementation of new packaging capabilities required to support future business growth and evolving customer requirements.
Ensure packaging areas maintain inspection readiness and meet safety, housekeeping, and environmental requirements.
Ensure all employees are appropriately trained and qualified for assigned responsibilities and that training documentation is maintained in accordance with organizational and regulatory requirements.
Maintain effective working relationships with union representatives and ensure compliance with collective bargaining agreements and company policies.
Communicate effectively with internal stakeholders, site leadership, customers, and regulatory agencies as required.