Direct Materials Sciences Specialist/Expert

The Pharma Technical Operations (PT) Global MSAT & Engineering (PTT) group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today.

The PTT Materials Science Technical Specialist/Expert provides technical leadership for material topics, implementing material-driven solutions across PT manufacturing and distribution networks that are aligned with internal and external regulations. Leveraging manufacturing expertise, the Technical Expert applies material science and data-driven knowledge to solve complex problems. Integration and the ability to navigate the technical material lifecycle and/or new regulations are often necessary to ensure a robust and flexible supply chain for direct materials, supporting the Product Health of our products from a technical perspective.

In this position you utilize material science expertise and product technical knowledge to support the product portfolio and the internal and external manufacturing network, ensuring manufacturing continuity and compliance with industry requirements. Furthermore you:

• Have a working knowledge of drug substance (cell culture, purification, formulation), drug product (filling and/or packaging), and/or small molecule processes to drive fit-for-purpose material solutions for the manufacturing sites.

• Apply material knowledge to assess the performance of manufacturing processes at a network and portfolio level, leading strategic improvements related to robustness, speed, efficiency, safety, and sustainability, with a focus on materials.

• Lead or participate at cross-functional teams to ensure network material standardization, address critical material issues or develop, improve and implement material-related business processes in order to demonstrate understanding and implementation of single use technologies (including technical design, technical drawings, etc).

• Represent PT as the material technical lead to external stakeholders (i.e. suppliers, including technical visits and audits).

• Lead key projects related to technical material lifecycle management, standardization, and new material implementation, ensuring alignment with Product Health goals.

• Interact with site (e.g., local MSAT, Manufacturing, QC) or global (Procurement, Supplier Quality, PTD) functions to identify appropriate materials or support identification of alternate materials or second suppliers.

• Collaborate with Specification and Filing teams within the Direct Material Management department to identify and implement fit-for-purpose materials, applying process requirements to support regulatory compliance.

• Serve as a recognized material expert by actively participating in deviation triages or CAPAs (local and global) related to direct materials, ensuring timely and appropriate action.

You have a BS/MS/PhD (preferably in Science or Engineering-related fields) with at least 4 years of experience in the pharmaceutical, biopharmaceutical, or medical device industry, or an equivalent combination of education and experience. Furthermore you have:

• Expertise in raw materials, including material science, critical attribute assessments, and specifications, with a strong track record in pharmaceutical manufacturing, focusing on drug product manufacturing.

• Strong background in designing, implementing, and using single-use materials for drug product aseptic filling is an advantage.

• Demonstrated project management skills with working knowledge of ICH guidelines, GMP operations, and health authority regulations.

• Ability to interpret and apply Roche Quality standards, ensuring compliance through effective use of Quality Systems such as CAPA, Change Management, and risk assessment tools. Strong quality mindset with meticulous attention to detail and a commitment to service excellence.

• <10% of travel required

Apply now to explore this exciting opportunity!

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of Oceanside California is $115,000 - $213,600. 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

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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.

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