MSAT Tech Transfer and Process Engineer Manager

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Primary Purpose of Job (Job Summary)

The MSAT Tech Transfer (TT) and Process Engineering (PE) Manager is a critical technical and leadership role responsible for ensuring successful execution of technical transfer projects and robust process engineering strategies in a cGMP environment. This position emphasizes technical transfer and Single-Use Technologies (SUT), and focuses on optimizing Drug Product (DP) manufacturing processes to achieve operational excellence in a highly regulated biopharmaceutical environment. Ensuring products are executed safely and timely in full compliance and consistency with GMP/ EHS requirements and Roche’s corporate principles, quality policies and standards.

• Enable and empower your team to deliver our vision through demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviors and focusing on strategic project development in China.
• Lead Tech Transfer, PPM introduction, SUT strategy and implementation, and Compliance, provide technical support and drive Improvement
• The role plays a critical part in strategic project realization including facility design, qualification and manufacturing readiness and start up.
• The role is key interface with the MFG, QA, ENG to ensure production smooth and efficient running and drive consistency between the different teams with the department.

Principle Roles & Responsibilities / Accountabilities

Leadership & People Management

• Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers, develop people and technical capabilities; build an environment which enables people to perform at their best.
• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion.
• Build and maintain strong partnerships with site leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
• Implement site EHS procedure and program and achieve site corporate /site EHS KPI. Promote EHS culture and improve employee safety behavior.
• Lead, coach, and guide the organization. Manage performance and development team members to achieve organizational goals and employee personal and professional growth
• Build a strong pipeline of talent and robust succession plans for key positions.
• Maintain a culture of continuous improvement and model lean leadership principles
• Maintain a culture of transparent, high performance, empowerment and innovation culture.

Technical

Engineering Project Support and Operation Readiness:

• Participate in new facility design and construction, including but not limited to process design, equipment selection, URS review, FAT, SAT, IOPQ, APS etc. to contribution on project delivery.
• Lead and develop a high-performing process engineering team, fostering a culture of innovation, technical rigor, and cross-functional collaboration.
• Act as a technical SME and people leader, guiding team members in Tech Transfer, SUT implementation, manufacturing support and troubleshooting.
• Partner with MSAT leadership to align process engineering strategies with site and global technical roadmaps.

Routine Operation:

• Tech Transfer and Process Engineering: Serve as a Subject Matter Expert (SME) in Tech Transfer, driving adoption across upstream/downstream processes. Optimize process for aseptic processing, cost efficiency, and, ensuring scalability, robustness, and compliance with global standards (FDA, EMA, cGMP).
• Technical Support & Continuous Improvement: Provide real-time process engineering guidance during manufacturing campaigns, resolving deviations, and implementing CAPAs. Collaborate cross-functionally (Engineering, Quality, Validation) to troubleshoot issues, drive root-cause analysis, and enhance process robustness, yield, and quality via data-driven innovation.
• Innovation: Partner with global teams to introduce new technology into GMP manufacturing, contribute to ensuring seamless scale-up and execution.
• Support regulatory filings (e.g., BLA, MAA) by providing PE expertise in CMC modules and responding to agency queries. Represents the facility during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

Qualification and Experience

Education/Qualifications

• Bachelor’s Degree (Pharmaceutical / Biological is preferred) and above

Job Required Competencies

• 10 or more years’ MSAT experience in the injection pharmaceutical industry, MNC Bio-pharma preferred
• 5 or more years Tech Transfer and Process Engineering experience
• 5 or more years’ people management experience
• Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
• Experienced in new facility startup readiness and operation ramp up including organization, people and operation management system
• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry
• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
• Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.