Director, MSAT (Drug Product)

Genentech; Holly Springs (NC); On-site; USD 151,000 - 281,000; Full time

Benefits offered by this job

Relocation benefits

Accommodations for Applicants

Job summary

Genentech in Holly Springs, NC seeks a seasoned MSAT Process Engineering Lead to guide a group of engineers through design, qualification, startup and regulatory filing at a state-of-the-art manufacturing site.

You will oversee compounding, filling, inspection of sterile drug products, drive cGMP compliance, and develop regulatory strategies with global teams to enable the 2028 plant launch. Relocation benefits are provided to support a ground-up site build.

Qualifications

• Bachelor’s/Master’s/Ph.D. in bio/chemical engineering or related field with 12+ years in pharmaceutical tech.
• Minimum 5 years of people management experience.
• Expert in drug product manufacturing operations (Compounding, Filling, Inspection).
• Experience with technology transfers, process validation, regulatory submissions and inspections.
• Up-to-date knowledge of cGMPs and Quality Systems.

Responsibilities

• Provide coaching and development opportunities to direct reports.
• Oversee design, qualification, startup and regulatory filing strategy for site processes.
• Lead process equipment design and implementation to meet regulatory requirements.
• Ensure quality systems, SOPs, and tech transfer activities on site.
• Develop risk assessments and PPQ prerequisites for site startup and launch.

Skills

People management

Process engineering

Data science / analytics

Regulatory submissions

Smart factory / Industry 4.0

Education

Bachelor’s/Master’s/Ph.D. in bio/chemical engineering or related

Job description

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.

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 joining the organization. You will act as a coach for colleagues with less experience and helps them develop skills/expertise

Who you are

• You hold a Bachelor’s, Master’s, or Ph.D. degree in bio/chemical engineering or similar and have 12+ years experience in technology of pharmaceutical industry
• Minimum of 5 years of people management experience
• You are a 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
• You have up-to-date knowledge of cGMP’s, Health Authority regulations, and Quality Systems

Preferred

• You are 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
• You have advanced project management skills: demonstrated ability of technology implementation and start-up
• You have 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

Work Environment/Safety Considerations

• This role requires full onsite work at the project office before transitioning to the site offices
• Ability to work in an international/global environment. Domestic and international travel required. Travel up to 20% after full relocation

• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $151,000 - $281,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance

Relocation benefits are provided

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants