MSAT Manager in Plant

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职位

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.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。