Genentech · 9 hours ago
Process Engineering Lead - Formulation, Filling, Inspection (CVRM)
Holly Springs, NC
Full-time
Hybrid
Senior Level, Lead/Staff
$114K/yr - $257K/yr
11+ years expGenentech is a leader in pharmaceutical manufacturing, and they are seeking a highly experienced Process Engineering Lead to oversee process design and qualification at a new manufacturing site. The role involves providing scientific and technical leadership, collaborating with various teams, and ensuring compliance with regulatory requirements during the startup of the facility.
BiotechnologyLife ScienceManufacturing
Responsibilities
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
Qualification
Required
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
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are provided.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
CEO
Michael Laird
Vice President
Recent News
2025-12-30
Pharmaceutical Technology
2025-12-29
Pharmaceutical Technology
2025-12-24
Company data provided by crunchbase