Process Engineering Lead - Formulation, Filling, Inspection (CVRM)

Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of Drug Product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinates all aspects of production of Roche medicines in all disease areas and dosage forms

To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).

The Opportunity:

We're seeking a highly experienced and strategic Process Engineering Lead to oversee all process design, qualification, startup and registration at our state-of-the-art manufacturing site focusing on the Compounding/Formulation, Aseptic Filling, and Final Vial Inspection operations of the DP Process. We're looking to offer multiple positions, and candidates will plan to be assigned to specific parts of the DP Process based on experience and business need, which means there plans to be a Compounding/Formulation Lead, an Aseptic Filling Lead, and a Final Vial Inspection Lead as separate positions filled through this job posting.

In this exciting role, you will be an integral member of the User Team and will provide scientific and technical leadership for the new large volume manufacturing facility in Holly Springs. In partnership with the Engineering and the start-up project (user) team, you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility. This role specifically is about the design, qualification, start-up and registration of the facility's compounding area, filling lines, and inspection linesand its processes. Following go-live of the facility, you will transition into a routine position in the site and will extend into daily operation responsibilities.

Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

• You will support the project leadership and co-lead project teams thereby driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line to meet product and cGMP/regulatory requirements. You will champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management. This also includes provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects.

• Together with the suppliers and contractors, you will build all required processes, documents, tests to transition the design plans into a functioning, approved manufacturing process.

• You will foster a positive safety culture in which no one gets hurt and ensure the integration of environmental health, safety, and security into the business and manufacturing processes, systems, and programs while reporting safety and environmental incidents within one's functional area.

• You understand the bigger picture of the project and large volume low cost manufacturing as part of the CVRM disease area and how Pharma Technical (PT) contributes to it. You will work closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. You will effectively partner with and influence stakeholders across the broader organization without formal authority, and drive technical decisions balancing project, product, quality/regulatory and operations views.

• 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.

• You will design and execute studies and comparability protocols to support the required operations. You will contribute to cGMP documentation and regulatory filings.

Who you are:

• You hold a Bachelor's, Master's, or Ph.D. degree in bio/chemical engineering or similar and have 11+ years experience in technology of pharmaceutical industry

• 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, IT 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 desirable

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 are a recognized expert/recognized authority in practical and theoretical engineering of biopharmaceutical manufacturing processes.

• 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.

• You have strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources. You are able to coach others.

• You have up-to-date knowledge of cGMP's, Health Authority regulations, and Quality Systems.

Work Environment/Safety Considerations:

• 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.

• Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina for a senior principal engineer with 11-14 years of experience is $114,400 - $212,400. For a distinguished engineer with 15+ years of experience the salary range is $138,300 - $256,800. 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.

Link to 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.

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