Senior Technical Manager jobs in United States
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Metric Bio · 3 weeks ago

Senior Technical Manager

Metric Bio is a leading US-based Fill/Finish CDMO seeking a Senior Technical Product Lead to drive product and project leadership within a drug product contract manufacturing organization. The role involves overseeing the full product lifecycle, client engagement, and implementing technical and operational excellence initiatives to ensure efficient manufacturing processes.

Staffing & Recruiting
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Hiring Manager
Enrico Caterina
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Responsibilities

Lead and support proposal development, including technical review and input
Conduct facility fit and risk assessments for new manufacturing programs (e.g., FMEA, process impact evaluations)
Oversee technology transfer from development to GMP manufacturing, translating process data into batch records and SOPs
Deliver hands-on process training to manufacturing teams during tech transfer
Lead cross-functional process improvement initiatives to enhance GMP planning, scheduling, and execution
Manage the lifecycle of clinical and commercial manufacturing programs, maintaining detailed project plans and key milestones
Serve as the primary client interface, ensuring seamless communication and high-quality service delivery across internal and external stakeholders
Support investigations, root cause analysis, and implementation of CAPAs
Author and manage change controls for internal and client-driven projects
Partner with Manufacturing to drive operational excellence through continuous improvement initiatives

Qualification

Aseptic processingGMP regulationsProject managementProcess improvementTechnical writingCommunication skillsOrganizational skillsAdaptability

Required

Bachelor's degree in a scientific or engineering discipline (advanced degree preferred)
Minimum 8 years of experience in biotech or pharmaceutical manufacturing operations
At least 5 years of experience in project management within a biotech, pharma, or CDMO environment
Proven expertise in aseptic processing and drug product manufacturing
Strong knowledge of GMP regulations and compliance for biologics production
Demonstrated ability to analyze and improve manufacturing processes
Excellent communication and technical writing skills
Highly organized, adaptable, and effective at managing multiple complex projects in a fast-paced, customer-focused environment

Preferred

advanced degree preferred

Benefits

Relocation support is provided!

Company

Metric Bio

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Utilizing our expertise to provide recruitment solutions to some of the worlds most cutting-edge companies in MedTech and Life Science.

Funding

Current Stage
Growth Stage
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