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The Position Background: Local support at the CMO Gosun in Shenzhen for the upcoming technology transfer of Avastin drug product filling, visual inspection and secondary packaging to Gosun, subsequently followed by Herceptin SC and Phesgo.
Role Description:
• Work closely with and support the Technical Transfer team to manage and meet the deliverables and timelines for process and method transfers at Gosun and Shanghai.
• Act as liaison between the transfer team and Gosun.
• Manage and ensure Drug Substance (DS) import and shipment to Gosun in time for technical transfers.
• Manage and ensure sample shipment between Gosun and Shanghai per project plans.
• Support the Gosun team in writing and completing product specific validation and qualification plans and reviewing them locally with the respective QA person.
• Review and approve Chinese and English documentation.
• Observe operational activities like media fills, test runs, technical batches as a Person in Plant (PiP) and capture observation minutes, drive and coordinate technical mitigation activities and troubleshooting.
• Oversee GMP compliant documentation of the activities in collaboration with the QA in plant
• Support the technical gap analyses and according risk assessments in the context of the Technical Transfers
• Support the Gosun team in defining, installing and qualifying the missing operational steps / equipment, e.g.: • compounding and API Handling for Herceptine SC and Phesgo
• secondary packaging process for all products
• Establish robust shipping processes for samples, goods and product between Gosun and Shanghai in collaboration with the Shanghai team
• Coordinate documentation review of relevant documentation with the Shanghai team (e.g. batch documentation)
• Collaborate with Roche global stakeholders to coordinate local activities at Gosun with global functions (e.g. TTLs, Site manager, ext. QA). Participate in JMT and project meetings to track actions and milestones
• Act as SPOC in country to the respective logistic, regulatory and quality teams
Capability Requirements:
• Strong background in sterile manufacturing • sound understanding of the manufacturing process requirements for aseptic filling, compounding, DS freeze / thaw, visual inspection and packaging
• experience in sterile manufacturing of biologics products
• sound knowledge of respective quality/regulatory requirements, including EU Annex-1
• Experience with Single-use technology is a plus
• Strong communication skills in English and Chinese
• Can navigate through ambiguity and uncertainty
• Ability to spend approx. 40% - 60 % working time at Shenzhen and willingness to travel between Shanghai and Shenzhen.
Who we are 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.