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SalaryElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The Role:
ElevateBio is looking for a Senior Manufacturing Specialist that will support all aspects of technical documentation, investigations, change controls, and compliance support for the manufacturing organization at BaseCamp Waltham.
Here's What You'll Do:
- Ownership of quality and technical documentation for manufacturing including Discrepancies and/or Deviations, CAPAs and Change Controls (including initiation, investigation, root cause analysis with cross functional groups and closure)
- Generate, revise, review and approve Standard Operating Procedures (SOPs), batch records and other documents to support manufacturing processes and programs
- Recommend and/or support implementation of Operational Excellence programs supporting efficiencies in execution and across BaseCamp
- Support organization and delivery of technical and quality training to manufacturing team, as applicable. Create, assign, perform, and maintain training for manufacturing staff, as applicable.
- Support project team environment with project deliverables
- Support cleanroom operations including cleanroom maintenance and cleaning, as applicable
Requirements:
- Minimum Bachelor's Degree in Engineering, Biotech, or a related field
- At least 5 years of experience in a Manufacturing, Technical Operations, or GMP environment supporting complex products. Experience in autologous gene or cell therapy a plus.
- Experience working within a contract manufacturing or client service organization strongly preferred.
- Familiarity with manufacturing/quality architectures and systems (e.g. SAP, electronic batch records, Veeva)
- Demonstrated ability and strength in leading cross-functional teams
- Strong attention to detail supported by excellent time management and organizational skills
Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
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.
