At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Roche is seeking a highly skilled and top-tier talenta professional who demands excellence and possesses the competency and experience in both greenfield engineering projects and routine operations. This position will spearhead drug product (DP) formulation and filling (F&F) and operational readiness efforts at our state-of-the-art greenfield biopharmaceutical manufacturing facility in Shanghai. This role focuses on driving excellence in aseptic formulation and fill-and-finish operations ensuring cutting-edge technologies and processes are seamlessly integrated into Roches manufacturing modelwhile maintaining compliance with cGMP/SHE and Roches quality addition the critical position emphasizes the successful execution of technical transfers process validation and the operational readiness of aseptic formulation and filling workflows ultimately achieving ramp-up and sustained operational excellence.

The MSAT F&F Lead/Subject Matter Expert (SME) is a pivotal technical role designed for exceptional professionals who bring unparalleled expertise and innovative solutions in formulation aseptic filling processes and related technologies essential for biopharmaceutical manufacturing. The ideal candidate will be an influential collaborator within the team demonstrating significant technical depth capable of addressing complex challenges and advancing Roches global manufacturing strategy. Furthermore the F&F SME will actively contribute to risk management and seamless technology transfers while fostering partnerships between cross-functional stakeholders to ensure strategic alignment. By contributing at a strategic level the F&F SME will not only support the development of advanced processes but also champion lean manufacturing principles innovation and best practices aligned with Roches vision. This highly collaborative role requires a strong focus on compliance operational excellence and global knowledge-sharing to improve the efficiency quality and scalability of aseptic manufacturing processes.

Formulation and Fill Strategy & Execution:

• Serve as a technical authority and strategic advisor for SUT in aseptic formulation and aseptic fill-and-finish operations ensuring the implementation of state-of-the-art processes that align with cGMP/SHE standards and Roches quality policies.

• Provide comprehensive technical oversight of aseptic processes integrating innovative approaches for formulation optimization precise filling accuracy and container closure integrity ensuring uncompromised product quality and sterility.

• Develop and standardize formulation and filling workflows encompassing advanced techniques for container selection and integrity testing to deliver robust performance across all product lifecycle stages.

• Serve as an expert in troubleshooting and optimization enabling seamless scale-up production readiness and long-term operational excellence within Roches global aseptic manufacturing framework.

• Champion the introduction of advanced F&F technologies and methodologies such as inline monitoring automated systems and real-time quality controls to improve operational agility and accelerate time-to-market.

Technology Transfer & Operations:

• Drive the technical transfer of formulation and aseptic filling processes ensuring seamless integration of new product introductions (NPI) into commercial production workflows.

• Drive technical innovation by identifying evaluating and implementing advanced technologies and methodologies to enhance process control automation capabilities and product quality consistency.

• Define and execute technical transfer strategies aligned with site priorities global supply chain requirements and Roches overarching operational strategy.

Influential Leadership & Global Interaction:

• Demonstrates strong creative leadership mindset and skills with a proven ability to cultivate a forward-thinking outlook and effectively eliminate barriers to progress.

• Collaborate with cross-functional teams (R&D QA Engineering Supply Chain) to ensure the implementation optimization and alignment of F&F processes.

• Acts as a mentor and coach to less experienced colleagues providing guidance in mastering complex F&F workflows troubleshooting technical challenges and developing skills in aseptic manufacturing science and technology.

• Facilitate robust interaction and collaboration with global team members internal stakeholders and external partners to support the aseptic manufacturing excellence.

• Provide timely updates promote effective knowledge sharing and establish efficient coordination mechanisms to drive alignment on key initiatives and project milestones.

• Lead efforts in CMO support ensuring external production partners meet Roches technical regulatory and quality requirements.

Roles & Responsibilities

Technical

Engineering Project and Site Start-Up Support:

• Participate in the design and construction of new facilities including but not limited to process design equipment selection URS review FAT SAT IOPQ APS and other aspects related to F&F thereby contributing to project delivery.

• Lead the development implementation and maintenance of F&F systems ensuring integration into overall facility workflows.

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

• Provide critical expertise contribute and deeply involved in the Fit for Future (FFU) program ensuring successful site start-up of MSAT operations.

Technical Expertise & Innovation

• Lead the design execution and optimization of formulation and filling processes including the integration of advanced technologies like inline monitoring automated filling systems and real-time quality monitoring tools.

• Evaluate novel formulation and filling methodologies for scalability sterility and reliability; perform gap analyses and technical feasibility studies to inform long-term strategies.

• Develop risk management frameworks (e.g. FMEA and control strategies) specific to formulation and fill operations addressing critical process parameters to ensure sterility and product quality consistency.

• Takes the lead in addressing unique or unprecedented challenges such as mitigating aseptic process risks or optimizing fill-and-finish facility startups with a measurable impact on production readiness and operational efficiency.

• Drive technical innovation by implementing digital and automated solutions to enhance equipment performance reduce batch discrepancies and improve overall operational flexibility at the site.

• Champion continuous improvement initiatives targeting process robustness waste reduction faster cycle times and optimized equipment performance with a focus on compliance cost-efficiency and sustainability.

Technical Transfer & Cross-Functional Collaboration

• Deeply involved in the end-to-end technical transfer from R&D to commercial manufacturing ensuring alignment of process parameters system integration and facility readiness.

• Develop review and maintain technical documentation while driving knowledge transfer and training initiatives to ensure operational readiness and continuous capability building within cross-functional teams.

• Author and review technical documentation related to formulation and filling processes including risk assessments validation protocols process descriptions and key sections of technical transfer dossiers.

• Act as the primary technical advisor during global and site-level technology transfers ensuring compliance with cGMP requirements while addressing risks and challenges encountered during scale-up and commercialization.

Manufacturing Support & Compliance

• Provide real-time technical guidance to production teams on issues related to formulation optimization aseptic behavior container integrity troubleshooting and batch deviations during routine operations.

• Possess a deep understanding of aseptic regulations and standards across various countries (e.g. FDA EMA NMPA and WHO guidelines) to ensure compliance with international regulatory expectations in aseptic formulation and filling processes.

• Lead root cause analysis and implement sustainable solutions for F&F deviations and non-conformances driving continuous improvement of aseptic processes and filling operations.

Leadership

• Possesses strong creative leadership aligned with the VACC model with a proven ability to foster innovation shape forward-thinking perspectives and overcome obstacles.

• Support Roches mission of advancing and boldly championing diversity equity and inclusion.

• Establish and sustain strong partnerships with site leaders to ensure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

• Contribute to a culture of continuous improvement and model lean leadership principles.

• Foster a culture of transparency high performance empowerment and innovation.

• Represent Roche MSAT in external F&F forums conferences and working groups to benchmark against industry best practices.

• Collaborate with F&F vendors to co-develop solutions aligned with Roches strategic priorities (e.g. flexible filling systems advanced aseptic technologies).

Qualification and Experience

Education/Qualifications

• Bachelors Degree (Pharmaceutical / Biological is preferred) and above

Job Required Competencies

• At least 5 years of experience in formulation and/or aseptic filling with a minimum of 8 years MSAT/Technical or operation experience in the injection pharmaceutical industry MNC Bio-pharma preferred

• Prior experience in visual inspection and packaging/LPD is advantageous

• Prior experience in people management is advantageous

• Proven expertise in strategic project of Aseptic Filling facility including design commissioning & qualification

• Hands-on experience in new facility startup readiness and operational ramp-up processes

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

• Ability to think strategically translate high-level strategies into actionable plans and embrace agile methodologies to foster adaptability and effectiveness

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

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.