Director, MSAT (Drug Product)

Roche•Holly Springs, NC

1d•$151,000 - $281,000•Onsite

About The Position

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. 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.

Requirements

Bachelor’s, Master’s, or Ph.D. degree in bio/chemical engineering or similar
12+ years experience in technology of pharmaceutical industry
Minimum of 5 years of people management experience
Recognized expert (technical and/or operational) in drug product manufacturing relevant unit operations (Compounding, Filling, Inspection)
Relevant experience in data science/engineering, analytics, etc. to drive the concept of smart factory is desirable
Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections is required
Up-to-date knowledge of cGMP’s, Health Authority regulations, and Quality Systems

Nice To Haves

Able to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results
Advanced project management skills: demonstrated ability of technology implementation and start-up
Relevant contact with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters
Utilizes an established network for technical issues within the company and the industry

Responsibilities

Provide clear objectives, coaching, and continued development opportunities to direct reports
Support the project leadership and co-lead project teams to ensure the processes implemented meet cGMP/regulatory requirements
Provide technical expertise and input on the design and implementation of production equipment
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
Ensure processes transferred meet characterization expectations for critical and key process parameters
Ensure proper implementation of process and microbial control strategies for all processes implemented at site
Design and execute studies and comparability protocols to support the required operations
Perform cross-functional risk assessments required for process controls
Ensure PPQ pre-requisites are met in time for site start up and launch
Participate in creation, review, and approval of regulator dossier section for site licensure
Provide input to strategic and streamlined approaches for all validation activities
Ensure appropriate specifications are in developed for direct raw materials and process IPCs and outputs and release
Foster a positive safety culture into the department and department operations ensure all SHE guideline are followed
Contribute to the continued improvements to OEE and process COGS
Ensure business continuity risk assessments are conducted on process raw materials, process quality characteristics, and identification of secondary suppliers
Provide knowledge and training on complex process and equipment technologies to all required partners
Provide training materials and training for people joining the organization
Act as a coach for colleagues with less experience and helps them develop skills/expertise