Manager, Manufacturing

Job Description

Responsible for ownership, execution, and governance of Manufacturing risk assessments and change controls. This role provides leadership to ensure risk‑based decision making, compliant execution of changes, and timely support of manufacturing operations while maintaining alignment with cGMP and regulatory expectations. The position collaborates closely with cross-functional partners and stakeholders to ensure risks are properly identified, assessed, mitigated, and documented, and manufacturing changes are effectively implemented without compromising product quality or supply.

RESPONSIBILITIES:

• Plans, executes, and tracks Manufacturing risk assessments and manufacturing‑driven change controls in coordination with cross‑functional departments, internally or externally.

• Provides focused ownership for Manufacturing risk assessment activities, including creation, updates, and periodic reviews, in alignment with approved methodologies and site procedures.

• Exercises judgment within generally well‑defined procedures and practices to determine appropriate actions related to risk‑based decisions and manufacturing changes.

• Normally receives no instruction on routine work and general instructions on new assignments.

• Oversees and contributes to the completion of technical and operational activities related to Manufacturing risk assessments and change controls through effective planning and prioritization.

• Manages complex processes across functions and interacts effectively with stakeholders to ensure regulatory requirements are met.

• Responsible for initiating and directing the implementation of Manufacturing changes across multiple projects and production areas, including coordination of impact assessments and approvals.

• Tracks risk assessment and change control activities against established timelines and adjusts priorities based on changing Manufacturing and business needs.

• Directs issue resolution and supports cross‑functional alignment throughout the lifecycle of risk assessments and change controls.

• Supports development and maintenance of training materials related to Manufacturing risk assessments and change controls.

• Creates, supports, or reports performance metrics related to risk assessment and change control execution and contributes to continuous improvement.

KNOWLEDGE & SKILLS

• Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of applicable regulatory requirements and guidance documents.

• Demonstrates understanding of risk‑based approaches within a Manufacturing environment.

• Is able to provide solutions to moderately complex to semi‑routine problems.

• Demonstrates excellent verbal, written, and interpersonal communication skills.

• Demonstrates strong computer, organizational, and project management skills.

• Demonstrates ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.

EDUCATION & EXPERIENCE

• 7+ years of relevant experience with a BS or BA preferred.

• 5+ years of relevant experience with an MS preferred.

• Prior experience in a cGMP‑related industry is required; biopharmaceutical or pharmaceutical manufacturing experience preferred.