Manager, Drug Substance Development & Manufacturing - Military veterans preferred

Cambrex


Manager, Drug Substance Development & Manufacturing

US-CO-Longmont

Job ID: 2025-4336
Type: Regular Full-Time
# of Openings: 1
Category: Drug Substance Manufacturing
Cambrex - Longmont

Overview

Position Summary:

The Manager in Drug Substance Manufacturing Operations works in a regulated cGMP environment within a Quality Management System and plays an important leadership role within the department. The manager supervises the chemical manufacturing operations as part of the DSDM management team. The manager is responsible for leading the manufacturing technical staff to enable the goals of the organization in Drug Substance Manufacturing with a focus on safety, quality, and right first-time metrics. The role is responsible for managing a team manufacturing specialists, execution of the production schedule, supervising manufacturing operations, equipment/suite readiness, staff training and ensuring compliance with safety and quality SOPs and policies throughout. This position will have supervisory responsibility for direct reports as assigned and will act in accordance and alignment with senior department management goals and mission.

Key Job Responsibilities:

• Supervises chemical manufacturing operations and proposes/implements actions under a continuous improvement and operational excellence environment in alignment with senior department management
• Determines responsibilities of assigned staff including daily schedule completion
• Supervisory responsibility includes performance management and career development of one or more direct reports as needed. May also direct others in task delegation in support of departmental senior management
• Responsible for ensuring department and staff compliance with and enforcement of all cGMP SOP’s, Safety SOP’s, site-specific policies, and procedures
• As needed, establish and maintain effective management systems to ensure success of the production schedule and supporting activities
• Provide expert guidance and support to staff in problem solving technical issues in manufacturing operations, quality investigations and CAPA implementation
• As part of the management team, responsible for safety incidents and quality deviations that occur and for their thorough investigation and timely reporting
• May perform direct drug substance operations in execution of a manufacturing batch record under GMP or non-GMP conditions as needed.
• Will contribute to department management of the GMP and non-GMP documentation processes including batch records and other quality documents used in the quality management system (change control, deviation, investigations, root cause analysis, CAPA, etc.) as needed or assigned.
• Will work with senior department management contributing to departmental direction, policy, strategy, proposal writing, production schedule, equipment onboarding and qualification, audit support and departmental training as needed or assigned.

Education & Experience

• S. or M.S. in Chemistry or related field and 8+ years in cGMP chemical manufacturing environment with increasing responsibility
• At least 3+ years supervisory experience with increasing responsibility
• Extensive experience and understanding needed of cGMP requirements and phase appropriate quality management systems (MBRs, change control, deviations, investigations, CAPAs, etc.)
• Knowledge of FDA, EU, and ICH requirements/guidelines and their implementation in the pharmaceutical industry

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