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About the Role
The Senior Large Molecule DS Product Steward is responsible for driving seamless technical industrialization and sustaining the technical health of commercial products throughout their lifecycle, from launch to divestment.
Responsibilities
- Identify, define, and deliver DS-related technical industrialization strategies and improvements for successful product launch, validation, robustness, cost-effectiveness, and compliance.
- Execute the product's technical strategic roadmap, including investigating and mitigating technical risks, implementing improvements, and aligning strategies with network objectives.
- Serve as the primary product technical owner for site leadership and quality functions during issue investigation.
- Represent the product in key technical governance forums and senior stakeholder interactions.
Requirements
- B.S. or M.S. degree in a scientific discipline (biotechnology, pharmacy, biology etc.).
- At least 7+ years of relevant industrial experience in platform specific process development or manufacturing operations.
- Proven record in Drug Substance or Drug Product manufacturing, product and technology industrialization, and process development in biological molecules.
- Demonstrated experience with technology transfer and/or process validation.
- Experience with pharmaceutical quality systems and industry-wide guidelines.
- Strong understanding of regulatory submission and health authority requirements.
- Understanding of patient needs/patient-centricity as key elements of design and delivery.
Skills
- Scientific expertise
- Industrial experience
- Leadership capabilities
- Platform specific process development
- Platform specific manufacturing operations
- Drug Substance manufacturing
- Drug Product manufacturing
- Product industrialization
- Technology industrialization
- Process development
- Biological molecules
- Technology transfer
- Process validation
- Pharmaceutical quality systems
- Regulatory submission
- Health authority requirements
Location
- California
Work Type
- Full-time
Experience Level
- Senior
- 7+ years
Education Level
- B.S.
- M.S.
- PhD is of advantage
Salary/Compensations
- $131,500 to $244,300
- A discretionary annual bonus may be available
Benefits
- Discretionary annual bonus
- Benefits detailed at the link provided below
About the Company
- PTT (MSAT & Engineering) ensures 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.
- 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.
Equal Opportunity
- 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.