Senior Manager, Manufacturing

About the role

ElevateBio is a technology‑driven company that helps partners realize the potential of their therapies from design to commercialization. The company is seeking a candidate to represent Manufacturing at its Pittsburgh facility. Initially, the role will focus on executing the Manufacturing site startup plan and associated projects to prepare the new facility for clinical and commercial manufacturing for US and EU markets. The position will later transition to oversight of manufacturing functions—including documents, training, metrics, investigations, functional projects, and systems—and may support on‑floor operations as needed.

Responsibilities

• Own manufacturing procedure revisions to reflect desired business processes.
• Support and review other functional documentation, including protocols and reports.
• Represent the manufacturing function for digital system and equipment design and implementation projects.
• Partner with MSAT on plans for initial tech transfer support and program onboarding.
• Support planning and implementation of site training program and implementation of EM and aseptic programs.
• Support procurement planning and execution, including onboarding of gowning, manufacturing vendors, GMP cleaning processes, etc.
• Review, trend, and present data to senior management on manufacturing performance.
• Oversee manufacturing deviation investigations for compliance and adherence to investigation best practices.
• Participate in regulatory inspections and facility audits.
• Support hiring and onboarding of site Manufacturing staff.

Requirements

• Bachelor’s degree with at least 8 years of related experience, OR Master’s degree with at least 6 years of related experience, OR PhD with at least 4 years of experience.
• Experience supervising teams of people.
• Experience in a Manufacturing, Quality, or GMP environment supporting complex products.
• Experience with autologous/allogeneic cell therapies or gene therapies is a plus.
• Experience with facility startup is a plus.
• Demonstrated ability to lead cross‑functional teams within a matrixed organization.

Physical and Environment Requirements

• Ability to stand, walk, bend and stretch for extended periods.
• Ability to lift 15–20 lb.
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions using arms, wrists, and hands.
• Ability to work nights, weekends, and holidays as needed to support business needs.