Engineer II, Global MSAT Support (Single Use Technology)

South San Francisco, California
United States

Job ID: 3239740921

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The Position

Location:  San Francisco

Engineer II, Global MSAT Support (Single Use Technology)

(South San Francisco)

Level E3 

This position is in the Global Biologics Manufacturing Science and Technology group, which supports GMP manufacturing of  Roche products at internal Roche/Genentech and External CMO and partner sites. This position will primarily focus on leading cross-functional projects, troubleshooting manufacturing and supplier issues, and aligning technical experts to define best practices for Single-Use Technologies (SUT) across the Global Biologics Manufacturing Network.  In this position, you will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. Full working knowledge and experience with Single-Use equipment qualification, design and operation is preferred.

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Lead and/or participate in global initiatives and cross-functional investigation and project teams
• Work collaboratively with Global Manufacturing Science and Technology (GMSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics
manufacturing network
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Travel of 10 - 40 % to support manufacturing sites and vendor collaboration will be required.
• Lead and co-lead Single-Use Tech Team and Single-Use Core Team meetings
• Support cohesion and alignment between Drug Substance and Drug Product technical teams, as well as leading multisite technical forums.

Internal Site Network Alignment

• Drive standardization of SUT requirements for DS /DP
• Support / Lead the Single-Use Tech Team and SU Core team in developing and maintaining a Single-Use Technology Strategies.

• Represent GBMSAT and the single-use category in meetings such as the Material Review Board (MRB) and the Single-Use Category Team (SUCat) and Supplier Quality Management (SQM) meetings as required
• Assist supplier quality groups as owner / technical assessor for SUT VICs
• Supports the implementations for new SUT applications at both DS and DP sites.
• Review extractable / leachable data packages from vendors. Compare to industry guidelines and internal acceptance criteria for GMP use.

CMO support

• Define the current state of CMO SUT conformance compared to Roche standards

• Identify gaps and propose a remediation plan to mitigate potential compliance risks
• Align CMO VIC management practices with internal Roche standards and multi-site VIC processes
• Support CMO technology transfers, audits, and regulatory filings pertaining to new and existing SUT items (e.g. antifoam bags, bioreactors, tubing sets, sampling containers, etc.)
• Support of existing MOC's and transfer of new processes using disposables at CMO locations
• Provide assistance with MOC assessments and VIC closure at CMO partners

Who You Are

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

• BS/MS/PhD. In Chemical/ Biochemical Engineering or Life Sciences with at least 3 years of relevant industrial experience or academia (including advanced studies) after receiving Bachelor’s degree.
• Experience with change control is required
• Self-motivated, able to work independently as well as in teams. Excellent organizational and communication skills (both written and verbal).
• Demonstrated proficiency in leading teams, experience leading cross-functional or cross-site teams is a plus.
• Proven ability to influence beyond direct line reporting relationships including to senior management.
• Full working knowledge and experience with Single-Use equipment qualification, design and operation. Experience with SUT vendor initiated changes and audit responses preferred. Strong problem-solving and troubleshooting skills to support polymer
chemistry analysis.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at EEO is the Law

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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