Senior Manager, Manufacturing

ElevateBio; Waltham (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

ElevateBio in Pittsburgh seeks an experienced manufacturing leader to direct site startup activities and oversee GMP manufacturing readiness for US and EU markets. You’ll drive procedural changes, digital systems implementations, and cross-functional programs, while transitioning to long-term oversight of manufacturing operations, training, documents, and investigations in a matrixed environment.

This role requires collaboration with MSAT, QA, engineering and external partners; prior leadership

Qualifications

• Bachelor’s degree plus 8+ years in manufacturing leadership within GMP or cell/gene therapy contexts.
• Experience supervising teams and coordinating cross-functional projects.
• Experience with facility startup is a plus.

Responsibilities

• Own site manufacturing procedures and revise documents to reflect new processes.
• Represent manufacturing in digital system and equipment design projects.
• Lead tech transfer planning with MSAT and onboarding programs.
• Support site training program development and implementation of EM and aseptic programs.
• Oversee vendor onboarding, GMP cleaning, and gowning processes.
• Review data, identify trends, and report to senior management.
• Participate in regulatory inspections and facility audits.
• Assist in hiring and onboarding site Manufacturing staff.

Skills

Team leadership

GMP manufacturing

Cross-functional collaboration

Regulatory inspections

Education

Bachelor’s degree in a life sciences or engineering field

Master’s degree in related field

PhD in life sciences

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role

ElevateBio is looking for an outstanding candidate to represent Manufacturing in our Pittsburgh facility. Initially, this role will be focused on execution of the Manufacturing site startup plan and associated projects needed to prepare our new facility for clinical and commercial manufacturing for US and EU markets. You’ll work collaboratively with the core team, internal subject matter experts, and external project team members to develop and implement procedural changes, digital systems, and business processes at the site according to a defined project plan. In operation, the position will transition to oversight of manufacturing functions including but not limited to documents, training, metrics, investigations, functional projects and systems and may support on-floor operations as needed to meet business goals. Candidates should have extensive experience with manufacturing in a GMP facility. This role is based on site in Pittsburgh.

Here’s What You’ll Do

• Own manufacturing procedure revisions to reflect desired business processes. Support/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 and at least 8 years of related experience, OR Master’s degree, and at least 6 years of related experience OR a 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 in autologous/allogeneic cell therapies or gene therapies is a plus.
• Experience with facility startup a plus.
• Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.

Physical and Environment Requirements:

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to lift 15-20 lbs
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions with use of arms, wrists and hands
• Ability to work nights, weekends, and holidays as needed to support business needs.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.