Biogen is an inclusive company of choice that advances the power of difference to drive innovative, equitable solutions. We are committed to building empathy, leveraging differences, and disrupting systems where bias may sit

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

What You'll Do

• Overseeing the manufacturing campaigns (partly on-site) at the CMO, including trouble-shooting in close cooperation with the CMO and internal stakeholders
• Responsible for execution of activities pertaining to tech transfer of drug substance and drug product manufacturing to CMO/CDMO, which includes initial process/facility fit, process transfer, manufacturing readiness, authoring of all respective reports including process performance qualification (PPQ) plan and -report
• Life cycle management of the manufacuturing process, including authoring of change control, deviation investigations, annual product reports and implemenation of process improvements.
• Authoring and reviewing commercial filing sections which are relevant for manufacturing
• Establish relationship with CMO/CDMO and closely collaborate with them for process implementation, -optimizations and trouble shooting
• Clearly and concisely report status updates to internal stakeholders

Who You Are

You are a person with strong experience in manufacturing and/or development of biologics drug substance and parenteral drug product manufacturing. Analyzing manufacturing processes for trouble shooting and optimizattion is nothing new to you and you are a teamplayer loving to work with internal and external stakeholders. You are able and willing to travel frequently from the office in Shanghai to our CMO/CDMOs.

• Experience in manufacturing of biologics drug substance and parenteral drug product
• Understanding CTD (filing) structure and -content
• Bachelor, Master Degree or PhD in pharmaceutical technology, bioprocessing engineering (chemical, pharmaceutical) or equivalent science study
• Approximately 6 years of relevant industry experience in biologics drug substance (DS) and/or drug product (DP) manufacturing and/or development for candidates with a BSc, 5 year with MSc, 3 years with PhD
• Ability to design manufacturing processes and develop PPQ strategy
• Leadership and communication skills (in English and Chinese) when working with internal and external stakeholders
• Strong analytical skills optimizing and trouble shooting manufacturing processes and implemnting solutions

About This Role

You are responsible for the execution of technology (tech) transfer (TT) projects including process performance qualification (PPQ), ensure adherence to the overall tech transfer schedule and the applicable tech transfer metrics. After completion of the TT, you are responsible for the entire life cycle of the manufacturing process. You must be able to lead the analysis of complex manufacturing and scale-up issues (trouble shooting) for biological drug substance (BDS)  and sterile injectable drug product. This role will be critical for ramping up manufacturing activities for biosimilars and other products of the portfolio. The role will be located in Shanghai, with frequent travel to CMOs mainly in China, but also to other locations in Asia and directly report to the team lead of the biosimilar external manufacturing sciences group in Baar (Switzerland).