The RoleElevateBio is looking for an outstanding candidate to represent Quality Control in our Pittsburgh facility. Initially, this role will be focused on execution of the Quality Control 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. This role will also assist with establishing the microbiology function in Pittsburgh to support laboratory/clean room start-up and qualification. In operation, the position will transition to oversight of quality control functions including but not limited to documents, training, metrics, investigations, functional projects, and logistics/outsourcing and may support on-floor lab operations as needed to meet business goals. Candidates should have extensive experience in a GMP manufacturing facility. This role is based on site in Pittsburgh.
Here's What You'll Do- Own quality control procedure revisions to reflect desired business processes. Support/review other functional documentation including protocols and reports.
- Partner with MSAT on plans for initial tech transfer support and program onboarding
- Assist in development, implementation, and maintenance of laboratory systems in compliance with applicable GMP practices and regulations.
- Support planning and implementation of site training program and implementation of EM and aseptic programs
- Review, trend and present data to senior management
- Oversee laboratory excursions, including; deviations, OOS, OOT and atypical investigations
- Participate in regulatory inspections and facility audits
- Hire, train and mentor staff
Requirements:- Bachelor's degree and at least 8 years of experience, OR Master's degree with 6 years of experience, OR PhD with at least 4 years of experience.
- Experience supervising teams of people.
- Experience with clean room qualification per ISO 14644
- Experience with compendial safety testing as well as rapid methodologies (BacT)
- Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP).
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMP, SOPs, and quality system processes.
- Excellent organizational skills.
- Experience in cell and gene therapy manufacturing environment a plus
- Experience performing laboratory investigations
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.
