Principal Packaging Engineer, Global Device and Packaging Development

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.

The Opportunity

In the Global Device and Packaging Development Department (PTDZ), we are responsible for the development of medical devices, combination products and packaging systems for R&D portfolio drug products. Our activities comprise a wide range of engineering disciplines ranging from the initial definition of product requirements to first commercialization considering required regulatory, legislative, ecological, economical and technical aspects.

Within the PTDZ organization sits a Global Packaging Development team responsible for designing and qualifying primary and secondary packaging systems for Roche global pipeline molecules including solid dosage forms, injectables, cell and gene therapies and combination products.

As a Principal Packaging Engineer, you will provide technical expertise in the development, qualification and deployment of new packaging systems, with a work plate heavily focused on leading pharmaceutical primary container and closure system topics for various therapeutical modalities such as biologics, small molecules, and gene & cell therapies. (e.g. Strategy definition for primary packaging, evaluation and development of new primary packaging components, definition / transfer of test methods, platform lifecycle management.). You will work on a variety of packaging initiatives and lead the development and qualification of global packaging solutions of assigned projects for clinical and commercial use. You will play a vital role in designing the best packaging for new molecules coming through the pipeline and launches. This activity involves close cooperation and cross-functional interaction with Technical Development Teams, Regulatory, MSAT, Operations, CMO's, Quality, Suppliers and other involved stakeholders.

What You'll Do

• Lead packaging engineering projects within global teams in order to meet predefined timelines, quality, and budget.

• Deliver innovative, best in class packaging solutions to meet patient and business needs.

• Develop and qualify global packaging solutions for products through the packaging lifecycle, understanding customer needs and leveraging the organization.

• Innovate: Evaluate and screen new technologies, and new materials and/or packaging solutions based on patient, product, regulatory, business or technical requirements.

• Ensure compliance with international procedures and external regulations.

• Actively support a culture of knowledge sharing and interaction across packaging and device development teams.

Pharmaceutical primary packaging responsibilities:

• Serve as pharmaceutical primary container and closure system expert for Roche global packaging community, including training and technical mentorship to team members in the department.

• Design and execute activities in support of components and container closure systems for non-combination drug product (e.g. glass vials, elastomeric stoppers, cartridges, and bags), including selection, characterization testing, and system qualification for dosage form-specific projects in alignment with quality system procedures and business practices. Provide technical review for components and container closure systems specifications and incoming release testing protocols.

• Contribute to safety assessments of material of construction of components and container closure systems.

• Provide technical expertise to the network for trouble-shooting primary packaging related issues including component defects, drug product manufacturing process and inspection.

Who You Are

• BS (minimum) in materials science, packaging engineering or related field

• Eight years of experience (minimum) working in packaging development lifecycle activities in the pharma/biotech/medical device industry

• Strong knowledge and experience in pharmaceutical primary container and closure systems required.

• Knowledge in extractables and leachables including associated industry standards and regulations.

• Technical expertise and hands-on experience in packaging design, test methods and packaging equipment and process qualification / validation.

• Sound knowledge of legislation, regulatory guidance and industry standards for packaging (e.g. ISTA/ASTM, design and validation / qualification, ISO, USP/EU/JP Compendia, ICH, and 21 CFR Part4).

• Excellent documentation practices: user requirements, design control, specifications, qualification protocols/reports for packaging systems, risk assessments, and shipping qualification activities.

• Project management skills and experience in cross-functional projects, excellent presentation and interpersonal skills and communication

• Traveling is required approx. 10-20%

This position can be located at the US Headquarters of Genentech in South San Francisco, CA (preferred) or remote work arrangements can be made (within US).

The expected salary range for this position based on the primary location of South San Francisco, CA is $109,500 - $203,300. 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

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.