Senior Large Molecule DS Product Steward

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 132,000 - 244,000; Full time

Job summary

Genentech, a member of the Roche group, seeks a Senior Large Molecule DS Product Steward to lead technical industrialization and maintain the product's technical health from manufacturability decisions through PPQ and supply maturity. You will own risk mitigation and drive improvements across the commercial lifecycle.

You will collaborate with site leadership and quality teams, aligning strategies with network objectives and regulatory expectations while overseeing product governance and

Qualifications

• B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc.), with at least 7+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations.
• Proven record in the Drug Substance or Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules.
• Demonstrated experience with technology transfer and/or with process validation and in pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing
• Strong understanding of regulatory submission and health authority requirements and of patient needs / patient-centricity as key elements of design and delivery.

Responsibilities

• Drive seamless technical industrialization and sustaining and improving the technical health of commercial products through PPQ, supply maturity and optimization.
• Deliver on the product’s technical strategic roadmap across the lifecycle, identifying risks and implementing improvements.
• Represent the product in key technical governance forums and with senior stakeholders.
• Serve as the primary product technical owner for site leadership and quality functions across the lifecycle.

Skills

Industrial experience in DS/DP

Process development

Technology transfer

Regulatory submission understanding

Quality systems knowledge

Education

B.S./M.S. in biotechnology/pharmacy/biology

PhD (advantage)

Job description

PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. Within PTT, Roche's global Manufacturing Science and Technology (gMSAT) department is the process and product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams.

The Opportunity

The Senior Large Molecule DS Product Steward is responsible for driving seamless technical industrialization and sustaining and improving the technical health of commercial products, starting from manufacturability decision through process performance qualification (PPQ), supply maturity and optimization, and ultimately divestment. Your main responsibilities cover Technical Industrialization (Develop Technical Strategic Roadmap) and Product Technical Health Management (Own & Mitigate Technical Risks): Identify, define, and deliver DS-related technical industrialization strategies and technical improvements to ensure successful launch as well as that the product remains validated, robust, cost-effective, and compliant. Deliver on the product’s technical strategic roadmap across the commercial lifecycle, as defined by an end-to-end Product Technical Lead, which includes investigating and mitigating technical risks, implementing improvements, and aligning strategies with broader network objectives. Serve as a primary product technical owner for site leadership and quality functions when investigating product or process issues across the commercial lifecycle. Represent the product in key technical governance forums and senior stakeholder interactions.

Who you are

The ideal candidate is a recognized authority in the field, bringing scientific expertise, industrial experience, and leadership capabilities. B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc. ), with at least 7+ years of relevant industrial experience in platform specific process development or in supporting platform specific manufacturing operations (e.g. DS Bio, DP SM etc.), PhD is of advantage Proven record in the Drug Substance or Drug Product manufacturing and product and technology industrialization as well as process development in the field of biological molecules. Demonstrated experience with technology transfer and/or with process validation and in pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing Strong understanding of regulatory submission and health authority requirements and of patient needs / patient-centricity as key elements of design and delivery.

Ready for the next step? We look forward to hearing from you.

Relocation benefits are not available for this posting.

Salary & Benefits

The expected salary range for this position based on the primary location of California is $131,500 to $244,300. 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. Benefits #LI-PK1 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.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

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.