Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.
The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
The Opportunity:
We're seeking a highly experienced and strategic MSAT Process Engineering Lead to manage a group of engineers through process design, qualification, startup and registration at our state-of-the-art manufacturing site. This position will oversee the process aspects of Compounding/Formulation/Filling/Inspection of sterile drug product, which will then be assembled and packaged into autoinjectors and multi-dose pens. This is a key role in site management to develop the process engineering staff to be interface to global technology implementation and development interfaces, as well as play a key role for developing the regulatory filing and approval strategy alongside the global and site functions.
What you’ll do:
You will provide clear objectives, coaching, and continued development opportunities to direct reports
You will support the project leadership and co-lead project teams to ensure the processes implemented meet cGMP/regulatory requirements
You will provide technical expertise and input on the design and implementation of production equipment
You will ensure implementation of quality systems and SOPs on site for tech transfer, filter validation, process validation, mixing characterization, leachable/extractables, aseptic simulations, and cleaning validations in conjunction with the site Validation Lead
You will ensure processes transferred meet characterization expectations for critical and key process parameters
You will ensure proper implementation of process and microbial control strategies for all processes implemented at site
You will design and execute studies and comparability protocols to support the required operations
You will perform cross-functional risk assessments required for process controls.
You will ensure PPQ pre-requisites are met in time for site start up and launch
You will participate in creation, review, and approval of regulator dossier section for site licensure
You will provide input to strategic and streamlined approaches for all validation activities
You will ensure appropriate specifications are in developed for direct raw materials and process IPCs and outputs and release.
You will foster a positive safety culture into the department and department operations ensure all SHE guideline are followed
You will contribute to the continued improvements to OEE and process COGS
You will ensure business continuity risk assessments are conducted on process raw materials, process quality characteristics, and identification of secondary suppliers
You will provide knowledge and training on complex process and equipment technologies to all required partners. You will provide training materials and training for people…