Head of MSAT Technology Transfer

Principle Roles & Responsibilities / Accountabilities

Leadership & People Management

• Exhibit exceptional leadership aligned with the VACC model, demonstrating a capacity to craft and execute forward-thinking strategies. Cultivate a high-impact environment by systematically eliminating barriers, advancing both people and technical capabilities, and enabling individuals to perform at their peak potential.

• Lead and develop a high-performing team, with a strong emphasis on people development, fostering individual growth, and enhancing collective skillsets to meet evolving organizational needs. Champion team building and cohesion to create a collaborative environment where shared success is prioritized.

• Serve as an unwavering advocate for Roche's mission of advancing and boldly championing diversity, equity, and inclusion, shaping an organizational ethos that reflects these pillars in all initiatives.

• Forge and sustain strategic alliances with site leaders to ensure alignment on high-priority initiatives, drive synergy across cross-functional operations, and achieve mutually advantageous relationships that deliver enduring organizational success.

• Oversee the implementation and continuous evolution of site SHE procedures, embedding best-in-class programs to surpass corporate/site SHE KPIs. Lead cultural transformation by embedding SHE principles into the organizational DNA and fostering a proactive employee safety mindset.

• Inspire, mentor, and direct the organization, while driving performance excellence and advancing team members’ development toward achieving both organizational objectives and their personal and professional aspirations.

• Build a strong pipeline of talent and robust succession plans for key positions.

• Spearhead a culture of relentless continuous improvement by embodying and advocating lean leadership principles, driving operational excellence that aligns with global benchmarks.

• Instill a transparent, innovation-driven, and high-performance culture built on empowerment, ownership, and bold thinking, ensuring the organization sustains a competitive edge in a dynamic market environment.

Technical

Engineering Project Support and Operation Readiness: 

• Actively contribute to the design and construction of the new facility, encompassing key activities such as IOPQ, APS, and process validation for seamless technology transfer, ensuring successful project execution and 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 Subject Matter Expert (SME) and people leader, guiding team members in Tech Transfer, manufacturing support and troubleshooting to drive operational excellence.

• Collaborate with MSAT leadership to align process engineering strategies with site and global technical roadmaps, ensuring seamless integration and strategic consistency.

Routine Operation: 

• Tech Transfer: Serve as a SME in Tech Transfer, leading the successful implementation and adoption of upstream and downstream processes while ensuring compliance with global regulatory standards (FDA, EMA, cGMP). Facilitate seamless process transfer, including scale-up and validation to achieve consistent, reproducible, and high-quality outcomes.

• Technical Support & Continuous Improvement: Provide technical expertise during the transfer and start-up phases, ensuring smooth integration of processes into the new facility. Address challenges related to scale-up, process validation, and initial production campaigns by troubleshooting issues, monitoring process performance, and implementing corrective measures. Collaborate cross-functionally to refine transferred processes for scalability, robustness, and compliance with regulatory standards, ensuring the successful realization of tech transfer objectives.

• Global Collaboration on Innovation: Partner with global teams to integrate cutting-edge technology into GMP manufacturing, facilitating seamless scale-up and execution. Contribute to innovation pipelines by participating in global technology forums and steering committees. Leverage insights from international collaborations to introduce advanced methodologies for process intensification, including novel bioreactor design, high-efficiency downstream processing systems, and process digitalization initiatives.

• Address agency inquiries with expertise and precision, represents the facility during regulatory inspections and audits, and participates in the response of regulator audit and global quality audit.

• Cross-Functional Project Leadership: Lead global, cross-functional projects by coordinating efforts between R&D, engineering, quality, and site operations teams. Ensure seamless integration of global requirements into local operations, driving shared ownership and accountability.

Qualification and Experience 能力与经验

Education/Qualifications 

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

Job Required Competencies 岗位所需胜任力 

• Over 10 years of MSAT experience in the injection pharmaceutical industry, MNC Bio-pharma preferred

• At least 5 years of hands-on experience in Tech Transfer

• A minimum of 5 years in people management, with a proven track record of leading and developing teams

• Extensive experience in strategic project of Aseptic Filling facility including design, commissioning & qualification 

• Expertise in new facility startup readiness including organization, people and operation management system

• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological industry 

• Demonstrates strategic thinking with the ability to translate high-level strategies into actionable plans; proficient in leveraging agile methodologies to drive efficiency and adaptability

• Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders