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South San Francisco, California, United States
Onsite
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche!
As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development.
As an integrated partner within the drug development ecosystem, Global Biologics Pharmaceutical Development is dedicated to effectively developing innovative and patient-centered parenteral drug products including Formulation and Process Development and Drug Delivery Systems.
The Senior Principal Process Engineer and Strategy Realization Lead ensures robust clinical and commercial parenteral drug product process designs for effective process validation and successful commercialization. This includes oversight and hands-on work at laboratory, pilot plant, and industrial scale of biopharmaceutical processing facility for process development, scale up, technology transfer and trouble shooting. Examples of pharmaceutical processing are liquid filling and finishing, prefilled syringe, drying technologies, bulk freezing and thawing, sterile filtration, mixing, primary container packaging development, etc. In this role, you are expected to work with formulation scientists, device engineers, and manufacturing staff to conduct drug product process development, perform technology transfers to internal and external CMO sites, as well as identify and define the critical steps and resources required to effectively resolve physical/biochemical and process issues encountered in those pharmaceutical operations.
Furthermore, you will collaborate within the Global Drug Product Process Engineering group to drive strategy harmonization and oversee seamless harmonized strategy deployment and right-first-time clinical and launch technology transfers and major market approvals. Harmonizing work across technical development functions and other Pharma Technical Operations network partners is crucial for success. A key component of the role involves providing strategic guidance across the DP process engineering network, ensuring the team's work supports the broader PTD Parenterals Development organization, including clinical and commercialization development phases, Drug Delivery, and Device Departments.
The Senior Principal Process Engineer and Strategy Realization Lead is also responsible for coaching/mentoring junior engineers for technical inspiration, championing new ideas, bringing in new technology for assessment, preparing patent applications and manuscripts for external publication, and presenting at national and international conferences/meetings.
As an experienced Senior Principal Process Engineer and Strategy Realization Lead with expertise in process development and launch experience in parenterals, you will play a crucial role in driving strategy harmonization and leading drug product process development within our global team. Your key responsibilities:
Develop, optimize, and validate robust processes for clinical and commercial parenteral drug products
Lead process design, validation studies, and technical transfers for seamless commercialization
Author and review relevant regulatory filing chapters and responses to information request questions from Regulatory Agencies.
Collaborate cross-functionally and across the parenteral pipeline portfolio to ensure strategic alignment and successful project execution
Foster innovation and continuous improvement in drug product and equipment processes
Ensure compliance with GMP and regulatory standards
Our ideal candidate will meet the following criteria:
Advanced studies or equivalent experience in a relevant scientific or engineering field
Relevant biopharmaceutical industry experience preferred, 5+ years with Ph.D, 9+ years with M.S., 12+ years with B.S.
Hands-on experience in aseptic process engineering
Expertise in parenteral process development and regulatory submissions
Experience with oligonucleotides, peptides and synthetic molecule parenterals is a plus
Strong leadership and project management capabilities
Excellent communication, strategic thinking, risk management and problem-solving skills
Relocation benefits are available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $143,300 - 266,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
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.
