MSAT Manager in Plant

About the role

Roche is looking for an MSAT Manager in Plant to provide local support at the CMO Gosun in Shenzhen for the technology transfer of Avastin drug product filling, visual inspection and secondary packaging to Gosun, followed by Herceptin SC and Phesgo. The role works closely with the Technical Transfer team and acts as liaison between the transfer team and Gosun.

Key responsibilities

• Manage and meet the deliverables and timelines for process and method transfers at Gosun and Shanghai, and act as liaison between the transfer team and Gosun
• Ensure Drug Substance import and shipment to Gosun and sample shipments between Gosun and Shanghai on time, per project plans
• Support the Gosun team in writing and completing product-specific validation and qualification plans and reviewing them locally with QA
• Review and approve Chinese and English documentation
• Observe operations such as media fills, test runs and technical batches as a Person in Plant, capture observation minutes, coordinate technical mitigation and troubleshooting, and oversee GMP-compliant documentation with QA in plant
• Support technical gap analyses and risk assessments, and help define, install and qualify missing operational steps and equipment (compounding and API handling for Herceptin SC and Phesgo, secondary packaging)
• Establish robust shipping processes for samples, goods and products between Shenzhen and Shanghai, and coordinate documentation reviews with the Shanghai team
• Collaborate with Roche global stakeholders (TTLs, site manager, external QA) and take part in JMT and project meetings; act as SPOC in country for logistics, regulatory and quality teams

Required profile

• Strong background in sterile manufacturing and experience in sterile manufacturing of biologic products
• Sound knowledge of quality and regulatory requirements, including EU Annex 1
• Strong communication skills in English and Chinese
• Able to work through ambiguity and uncertainty
• Willingness to spend about 40-60% of working time in Shenzhen and to travel between Shanghai and Shenzhen

Required skills

• Sterile manufacturing and aseptic filling, compounding, drug substance freeze/thaw, visual inspection and packaging
• Single-use technology is a plus