Job Description

Responsibilities:

• Execute the mission and strategy of internal cGMP manufacturing operations with a focus on safety, compliance, and operational excellence.
• Promote safety, quality, efficiency, and sustainability across all aspects of GMP production.
• Coordinate and manage resources to meet production schedules, quality standards, and cost targets.
• Provide support across multiple GMP manufacturing areas as needed.
• Assist in preparing for and participating in audits and regulatory inspections.
• Build and maintain effective cross-functional relationships across departments.
• Align manufacturing schedules with product supply forecasts and project milestones.
• Develop detailed production plans, assess risks, and create contingency strategies to ensure project delivery meets timelines, budgets, and quality expectations.
• Support facility and equipment qualifications, ensuring readiness to meet operational and regulatory requirements.
• Contribute to the drafting and review of manufacturing documentation, including batch records, SOPs, and technical reports.
• Assist in deviation investigations, change control processes, and CAPA implementation.

Qualifications:

• 0–3 years of relevant experience in cGMP manufacturing, with level of responsibility determined based on education and experience.
• Hands-on experience in a cGMP-regulated manufacturing environment; cell or gene therapy experience highly desirable.
• Strong understanding of facility design, process strategies, technology transfer, and GMP operations.
• Excellent verbal and written communication skills, with the ability to present information to technical and non-technical audiences.
• Demonstrated ability to work collaboratively, manage multiple priorities, and adapt to a fast-paced, dynamic environment.

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