The RoleElevateBio 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.
