Direct Materials Sciences Specialist/Expert

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 94,000 - 175,000; Full time

Job summary

Genentech is seeking a Materials Science Technical Specialist/Expert to lead material topics across PT manufacturing and distribution networks. You will apply material knowledge to drive robust, compliant solutions for direct materials across the network.

You will partner with site and global teams to standardize materials, implement new materials, and ensure alignment with Product Health goals while navigating regulatory requirements.

Qualifications

• Expertise in material science and drug substance/drug product materials.
• Experience with single-use materials for aseptic filling is a plus.
• Familiarity with ICH guidelines, GMP operations and health authority regulations.

Responsibilities

• Lead material lifecycle projects and standardization across PT networks.
• Collaborate with cross-functional teams to implement fit-for-purpose materials.
• Represent material tech lead to suppliers and conduct visits/audits.
• Apply quality systems (CAPA, Change Management, risk assessment) to materials.

Skills

Material science

Single-use materials

Project management

ICH/GMP knowledge

CAPA / Change management

Education

BS/MS/PhD in Science or Engineering

Job description

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.

The Opportunity

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.

• 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.

Who you are

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.

• 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.

The expected salary range for this position based on the primary location of California is $93,900 - $174,500. 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

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.