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