Director, MSAT (Drug Product)

About the role

Roche/Genentech is building a new $2B greenfield manufacturing site in Holly Springs, North Carolina, focused on high-volume, highly efficient drug product manufacturing for cardiovascular, renal and metabolism medicines, with a planned launch in 2028. The Director, MSAT (Drug Product) leads a group of engineers through process design, qualification, startup and registration, overseeing the process aspects of compounding, formulation, filling and inspection of sterile drug products that are assembled into autoinjectors and multi-dose pens. The role also supports regulatory filing and approval strategy and develops the process engineering team.

Key responsibilities

• Set clear objectives, coach and develop direct reports, and train colleagues and new hires.
• Support project leadership and co-lead project teams so processes meet cGMP and regulatory requirements.
• Provide technical input on production equipment design and implementation.
• Ensure quality systems and SOPs are implemented for tech transfer, filter validation, process validation, mixing characterization, leachable/extractables, aseptic simulations and cleaning validations, working with the site Validation Lead.
• Ensure transferred processes meet characterization expectations for critical and key process parameters, and implement process and microbial control strategies.
• Design and run studies and comparability protocols, and perform cross-functional risk assessments for process controls.
• Meet PPQ prerequisites for startup, help draft the regulator dossier section for site licensure, and advise on streamlined validation approaches.
• Develop specifications for raw materials, process IPCs and outputs, and ensure business continuity risk assessments and secondary supplier identification.
• Foster a positive safety culture, improve OEE and process COGS, and share knowledge of complex process and equipment technologies.

Required profile

• Bachelor's, Master's or Ph.D. in bio/chemical engineering or similar, with 12+ years of experience in pharmaceutical technology.
• At least 5 years of people management experience.
• Recognized expert in drug product manufacturing unit operations such as compounding, filling and inspection.
• Prior experience with technology transfers, process validation, regulatory submissions and Health Authority inspections.
• Full-time onsite work at the project office before moving to site offices; domestic and international travel up to 20% after relocation; possible clean room work requiring gowning.

Required skills

• Up-to-date knowledge of cGMP, Health Authority regulations and quality systems.
• Desirable: data science/engineering and analytics experience to support a smart factory approach.
• Advanced project management, technology implementation and start-up experience.
• Ability to influence senior management and coordinate with regulators, vendors and collaborators.

What we offer

• Salary range of $151,000 - $281,000 depending on experience and qualifications.
• Discretionary annual bonus and relocation benefits.