Senior Manager, Commercial Readiness Operations
ElevateBio 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 an outstanding candidate to represent Technical Operations on a cross-functional Commercial Readiness team. This role is responsible for supporting commercial readiness gap assessment and mitigation activities to prepare our facility and company for Phase 3/commercial manufacturing for US and EU markets. You’ll work collaboratively with internal subject matter experts and consultants to develop and implement procedural, system, and business process updates according to a defined project plan. Candidates should have extensive experience with manufacturing in a GMP facility, specifically in later phase assets.
This role will initially fully support Commercial Readiness program activities and will transition to a full-time role within MSAT/Technical Operations after the implementation of the project is complete (approximately 12 months). This role will report into the MSAT/Technical Operations function with dotted line reporting to the Commercial Readiness program lead and team.
Here’s What You’ll Do:
- Draft, write, and review updates to Standard Operating Procedures, Policies, Risk Assessments, and other documentation in accordance with project schedule and plan. Direct ownership of Technical Operations owned documentation and support/review of other functional documentation that is part of the project.
- Develop implementation plans and remediation plans as part of the implementation of new policies and programs. Support any gaps in compliance and remediation activities.
- Partner with Quality, CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets.
Requirements:
- Minimum Bachelor’s Degree in Engineering, Science, or related field.
- At least 8 years of experience in a Manufacturing, Technical Operations, Quality or GMP environment supporting complex products. Experience in autologous/allogeneic cell therapies or gene therapies is a plus.
- Direct experience working in a commercial manufacturing facility strongly preferred
- Experience and/or familiarity with regulatory guidelines (ex. FDA CFR, EU EudraLex/Annex) is a plus
- Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.
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.