Our client are a global leader and pioneer in the field of antibody-drug conjugates, they are experts in the lifecycle, from discovery to commercialization.

They are looking for a Director ofUpstream Manufacturingto be a member of the Technical Operations organization responsible for Upstream Manufacturing activities as well as bridging developing processes from research to GMP manufacturing activities.

You would have the following responsibilities:

• Work in collaboration with UK development researchers to bridge and transfer selected processes to CMO manufacturers. Responsibilities include cell line development and cell culture procedures transfer to CMOs as well as collaborate with ADCT Tech Ops downstream and conjugation SMEs to transfer research processes to manufacturing CMOs.

• Technically review new upstream Master Batch Records (seed train, production, primary recovery) for adherence to the Process Descriptions for a particular ADCT product

• Review executed Upstream Batch Records for adherence to the Process Description and extract data from the records into an electronic database for analysis

You would need the following qualifications:

• Masters / PhD in Biochemistry, Chemistry, or life science/engineering with appropriate biotechnology experience

• Extensive experience in Process Development/Manufacturing

• Experience with Technology Transfer from one production site to another, GMP general upstream and downstream manufacturing processes, process characterization, reviewing master batch records, with emphasis in upstream process development experience.

• Experience in performing upstream activities in a GMP manufacturing facility, have experience working with process development groups optimizing process fit and transfer to manufacturing CMOs.

Get in touch to find out more!