Senior Large Molecule DS Product Steward

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

Job summary

Genentech, a member of the Roche group and a pioneer in biotechnology, seeks a Senior Large Molecule DS Product Steward in California to drive seamless technical industrialization and sustain the technical health of commercial products, from manufacturability decisions through PPQ, supply maturity and optimization, with an expected salary range of $131,500 to $244,300.

You will own and mitigate technical risks, deliver on the product’s technical strategic roadmap, and act as the primary

Qualifications

• B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc.).
• At least 7+ years of industrial experience in platform-specific process development or manufacturing operations.
• PhD is advantageous.
• Proven record in Drug Substance or Drug Product manufacturing and process industrialization.
• Strong understanding of regulatory submission and health authority requirements.

Responsibilities

• Drive Technical Industrialization and Develop Technical Strategic Roadmap.
• Own & Mitigate Technical Risks across the commercial lifecycle.
• Represent the product in key technical governance forums and senior stakeholder interactions.
• Collaborate with site leadership and quality functions across lifecycle.

Skills

Leadership

Regulatory knowledge

Technology transfer

Process development

Industrial experience

Education

Bachelor/Master in biotechnology/pharmacy/biology

PhD advantageous

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.