Manager, Manufacturing, Science and Technology (MSAT)

Civica - Va State Univ, VA

Full-time - Mid Level

Va State Univ, VA

51-100 employees

Professional, Scientific, and Technical Services

About the position

The Manager, Manufacturing, Science and Technology (MSAT) at Civica will oversee the technical transfer and process support activities for New Product Introduction at the Petersburg site. This role involves collaboration with manufacturing and engineering teams to ensure successful technology transfers, while also working closely with R&D to develop and improve technical transfer processes that align with project and business objectives.

Responsibilities

• Lead the transfer of production processes and technologies from R&D into site operations.
• Develop process control strategy documents, technology transfer change controls, and engineering protocols in coordination with R&D.
• Ensure that the manufacturing batch record meets established conditions as defined in the CMC documentation.
• Manage process stewardship throughout the lifecycle of commercial manufacturing processes, including MBR creation and protocol development.
• Design Process Performance Qualification (PPQ) plans to validate manufacturing processes for commercial production.
• Oversee product technical lifecycle management, including process control strategy and batch deviations.
• Support product pre-approval inspections and interact with regulatory agencies during site inspections.
• Prepare and review cGMP documents such as batch records, technical protocols, and validation protocols.
• Collaborate with operations and validation teams to prepare aseptic core packages for submissions.
• Build subject matter expertise across functions in compounding, sterilization, and device assembly.
• Perform gap assessments for new product introductions and develop innovative solutions.
• Charter cross-functional tech transfer teams comprising R&D, QA, QC, Regulatory Affairs, and operations.
• Provide technical leadership for resolving technical issues impacting supply through investigations and root cause analysis.

Requirements

• Bachelor of Science in Engineering or a similar technical degree.
• Minimum of 6 years' experience in technical transfer and process validation.
• Experience in an FDA regulated environment.
• Experience in parenteral facility operations setting.
• Strong knowledge of current standards and regulatory expectations for pharmaceutical product development.

Nice-to-haves

• Postgraduate degree in a relevant field is desired but not required.
• Strong interpersonal, collaboration, and leadership skills.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities