Position Summary:

The Upstream Manufacturing Manager will report to the Sr. Director of Upstream Manufacturing. The role will be responsible for the supervision of a shift of 5 Manufacturing Technicians and an Associate on a rotating pitman (every other weekend off) 12 hour schedule (7am-7pm). The role's primary focus will be on cell culture operations from vial thaw through to 2K operations for the production of viral particles for gene therapy products.

• Provides on-the-floor leadership and development of Manufacturing Technicians across multiple clean rooms
• Sets clear expectations of staff to execute all activities in compliance with cGMP and EHS requirements
• Planning and supervision of daily tasks to achieve master production plan (MPP)
• Ability to be on call for Upstream MFG alarms off shift and manage response accordingly
• Escalate and manage response for manufacturing issues by partnering with support groups

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Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

Training

• Ensure efficient and compliant GTMF drug substance operations by mastering production and quality systems, overseeing team training, and collaborating on training material development.

Quality Systems

• Operate Veeva Vault for quality documentation and lead internal/external audits.
• Ensure cGMP compliance, oversee batch record reviews, and drive Lot Disposition activities.
• Own and close quality system items including SOPs, MBRs, risk assessments, and validation activities.

Documentation

• Create, revise, and maintain GMP documents (batch records, SOPs, OJTs, logbooks).
• Manage change controls and deviations, ensuring timely implementation and regulatory compliance.
• Uphold high cGMP documentation standards and meet schedule timelines.

Plant and Process

• Ensure readiness of materials, personnel, and documentation for processing; own upstream equipment.
• Lead Campaign Readiness, New Product Introduction, and Continuous Improvement initiatives.
• Maintain safety and GMP compliance across plant operations and processes.

Batch Ownership

• Act as first responder to floor issues, driving resolution through technical leadership.
• Supervise daily tasks to meet production targets and escalate risks appropriately.

Leadership

• Manage technician performance, training, safety, and career development.
• Lead cross-functional projects and foster strong communication across Manufacturing teams.

Requirements:

• Ideally, degree in Engineering or Scientific Discipline, equivalent education/experience could be considered
• Ability to be on call for Upstream MFG alarms off shift
• 10+ years’ experience, including leadership positions with direct reports ideally in Biologics including a 24/7 manufacturing environment
• Experience with GMP manufacturing of viral vectors and/or biological processes
• Strong collaboration, team-working skills, and communication skills

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment
• Certain tasks may require the use of a respirator; medical clearance will be required in advance
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment
• Working in temperature-controlled environments (cold rooms)

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