Senior Principal Process Engineer and Strategy Realization Lead

Roche • South San Francisco, CA

5d • Onsite

About The Position

As part of Pharma Technical Development (PTD), this organization is committed to delivering Pharma ambitions by bringing game-changing therapies from clinical phase I into the market. 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. 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.

Requirements

• 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
• Strong leadership and project management capabilities
• Excellent communication, strategic thinking, risk management and problem-solving skills

Nice To Haves

• Experience with oligonucleotides, peptides and synthetic molecule parenterals is a plus

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

Benefits

• Relocation benefits are available for this job posting.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed