Lonza: Study Director - Formulation & Stability

An exciting opportunity has become available within the Analytical Services function in the study direction department. The role involves the scientific oversight and management of a wide range of studies including characterisation, validation, formulation and stability studies.

The roles and responsibilites of the successful candidate will be

•         Write and review protocols to agreed timelines

•         Single point of control through study lifecycle and request work is scheduled and performed as per agreed study protocol for both GMP and non-GMP studies

•         Write and review of study reports, protocols, SOPs and policies

•         Ensure studies are compliant to current policies and guidelines

•         Talks to customers about specific study results as required in support of analytical product manager

•         Scientific interpretation of data, highlighting any unusual or atypical results and leading appropriate investigations

•         Responsible for leading OOS or OOT investigations

•         Coach and mentor junior scientists to write protocols and reports

•         Introduce process improvements for report and protocol writing

•         Support customer audits and regulatory as required

•         Perform gap analysis of customer reports and SOPs

Essential:    Demonstrated experience in study directing / managing a range of analytical studies for recombinant protein and IgG molecules

Demonstrated experience of scientific interpretation of data and troubleshooting (e.g. OOT/OOS)

Desired :     Experience of working in a contract research environment

Experience in mentoring and coaching junior scientists in order to deliver a successful analytical CMC package for erly phase and late phase products.

Demonstrated knowledge of regulatory and GMP processes

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