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 cell and gene therapy processes, programs, and companies to their full potential.

The Role:

ElevateBio is currently seeking a Director of Manufacturing Operations to oversee a team responsible for managing operations including supply chain, procurement, materials management, scheduling, and equipment validation. The Director will work closely with leadership and Project Management teams to understand programmatic mRNA needs and assist in in development of timelines, project plans, budgets to ensure readiness for GMP manufacturing. This is an opportunity for a detail-oriented leader who has a commitment to operational reliability and excellence. Ideally hands on experience and understanding of routine operation of mRNA production equipment, including but not limited to bioreactors, chromatography systems, media preparation, buffer preparation, raw material weigh/dispense, solution filtration, and final fill equipment. The Director will be expected to manage a portfolio of programs and interact with internal groups including Technical Operations, CMC operations and Project management, QC, QA, and Regulatory teams, as well as with external stakeholders including ElevateBio’ s collaborative partners.

Here’s What You’ll Do:

Provide strategic leadership for manufacturing function by defining strategy and roadmap for investment in people, process, and infrastructure to scalable support rapid business growth
Partner with internal and external teams to scale and improve existing products and transfer new products into manufacturing.
Foster a culture of continuous improvement of business processes in manufacturing.
Manage assigned departmental budget and allocate resources per company objectives.
Drive improvements in manufacturing service levels to both internal and external customers.
Critically review the performance of the products to ensure appropriate performance over time.
Oversee the successful technical transfer of newly developed products from partner to manufacturing.
Ensure that operations meet all quality objectives in line with company operating priorities.
Ensure compliance with health, safety, and environments laws and regulations, engaging all associates to make quality and safety a priority
Provide technical support and leadership for development and GMP manufacturing.
Review and approve GMP batch documentation, standard operating procedures and technical reports as needed.
Support investigations and root cause analysis and other laboratory investigations as needed.
Work closely with the Quality team to ensure compliance during GMP manufacturing including strategies to successfully implement manufacturing or quality control method changes

Requirements:

Bachelor’s Degree in bioprocessing, chemical engineering, or biological sciences
10+ years of experience (B.S. or M.S.) or 8+ years of experience (Ph.D) in biotech or pharmaceuticals working on human biologics in relevant roles associated with development, manufacturing, process engineering, quality or supply chain
Deep Experience leading GMP manufacturing facilities, preferably at late clinical stage or commercial phase
Understand the technology and process behind mRNA manufacturing
In-depth knowledge of US and EU regulations, GMP, ICH and Guidance’s for the Industry related to cell and gene therapy is required
Fluency in digital systems such as SAP, DeltaV, MES, etc.
Ability to communicate effectively with a diverse range of scientists, technicians, engineers, regulatory specialists, and business professionals
Experience providing clear leadership and orchestrating changes in a complex and fast-paced environment with competing priorities
Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement across the Value Stream
Lead the optimization, trending, and reporting of manufacturing process operational parameters for manufacturing campaigns and daily metrics

Why Join ElevateBio?

ElevateBio is accelerating access to the cutting-edge technologies and expertise that will change the future of medicine. Our ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene-editing platform; a proprietary induced pluripotent stem cell (iPSC) platform, and an RNA, cell, protein, and vector engineering platform – with BaseCamp®, our end-to-end genetic medicine cGMP manufacturing and process development business, to power the discovery and development of advanced therapeutics.

With these leading-edge platforms and capabilities, we are enabling a broad breadth of biopharmaceutical companies in the development of their novel cell and gene therapies while also building our own innovative pipeline of cellular, genetic, and regenerative medicines. Together, 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.

Average Compensation: $130,808

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