- Lead department to ensure consistent, reliable, timely and compliant manufacturing of products across all modalities at the site spanning clinical and commercial phases.
- Effectively partner with Quality, Facilities and Engineering, Supply Chain, and other functions to maintain procedures and processes for timely release of all manufactured products.
- Develop and maintain training records, operating procedures, and policies in accordance with Current Good Manufacturing Practices.
- Collaborate with process development and other subject matter experts to support internal and partner technology transfers into manufacturing.
- Develop short- and long-term goals for the department in accordance with overall corporate and site objectives. Create, measure, trend, and report manufacturing related KPIs as a basis to drive continuous improvement.
- Minimum Bachelor's Degree in Engineering, Biotech, Supply Chain, or related field
- At least 10 years of experience in a Manufacturing, Technical Operations, or GMP environment supporting complex products. Experience in autologous gene or cell therapy a plus.
- Direct oversight and experience leading in a commercial manufacturing team required. Direct oversight and leadership of teams > 30 FTEs and over multiple shifts strongly preferred.
- Experience working within a contract manufacturing or client service organization strongly preferred.
- Familiarity with manufacturing architectures and systems (e.g. SAP, electronic batch records)
- Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.
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Senior Director, Manufacturing - Waltham, MA, United States - ElevateBio
Description
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 a Head of Manufacturing that will oversee GMP manufacturing of genomic medicines including autologous and allogenic cell therapies, viral vectors, mRNA, and other modalities. The Head of Manufacturing will be responsible for leading and managing daily manufacturing activities to ensure safe and timely delivery for internal and client programs. The Head of Manufacturing is a key member of the BaseCamp Waltham Site Leadership Team and is a critical interface for our valued partnerships.
As a member of the BaseCamp Waltham Leadership Site Team, the incumbent will be responsible for helping set strategic direction for the site, in alignment with corporate goals and objectives, including transitioning to a commercial ready operation, manufacturing capacity expansion support, and launch of several client products.
Here's What You'll Do:
Requirements:
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.
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