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 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.
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.
Skills Required
- Bachelor's degree with at least 8 years of experience, or master's degree with 6 years, or PhD with 4 years
- Experience supervising teams
- Experience with cleanroom qualification under ISO 14644
- Experience with compendial safety testing and rapid methodologies such as BacT
- Experience with gene and cell therapy testing methodologies, including qPCR, ddPCR, flow cytometry, ELISA, and cell-based assays
- Experience with LIMS, CMMS, QMS, and ERP systems
- Ability to communicate and work independently with scientific and technical personnel
- Strong knowledge of GMP, SOPs, and quality system processes
- Excellent organizational skills
- Experience performing laboratory investigations
- Experience in a cell and gene therapy manufacturing environment
Elevatebio Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elevatebio and has not been reviewed or approved by Elevatebio.
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Healthcare Strength — Health coverage is characterized by comprehensive medical, dental, and vision plans with low deductibles and no copays for in‑network mental‑health visits, alongside employer‑paid wellness platforms and fitness reimbursement. Together, these elements indicate robust healthcare support.
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Retirement Support — Retirement benefits include a 401(k) with an employer match and immediate vesting, plus employer‑paid life and disability coverage and access to a 1‑on‑1 financial advisor. This combination signals solid long‑term financial support.
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Parental & Family Support — Family support includes fully paid parental leave, separate sick time and bereavement, and formal administration of federal and state leave programs. These provisions reflect meaningful support for new parents and caregiving needs.
Elevatebio Insights
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare. ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
