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

Comments

Post a Comment

Popular posts from this blog

Protein folding via charge zippers

Jan. 18, 2013 — Membrane proteins are the "molecular machines" in biological cell envelopes. They control diverse processes, such as the transport of molecules across the lipid membrane, signal transduction, and photosynthesis. Their shape, i.e. folding of the molecules, plays a decisive role in the formation of, e.g., pores in the cell membrane. In the journal Cell, researchers of Karlsruhe Institute of Technology and the University of Cagliari are now reporting a novel charge zipper principle used by proteins to form functional units. "It is fascinating to see the elegant basic principles that are used by nature to construct molecular assemblies," explains Anne Ulrich, Director of the KIT Institute for Biological Interfaces. "A charge zipper between the charged side chains is an entirely unexpected mechanism used by membrane proteins to neutralize their charges such that they can be immersed into hydrophobic cell membranes....
Read more

Lonza: CMC Product Manager

Due to the expansion of Lonza's Analytical Services department we are looking to recruit an Analytical Product Manager. Reporting to the Group Leader you will proactively coordinate internal and external client project activities (analytical CMC development of recombinant proteins) performed within Analytical Services and to provide scientific oversight of data generated for the projects. Responsibilities:      * Primary point of contact for all analytical activities relating to product development and management of analytical development programmes from early phase development through to license application.      * Primary interface to the Program Management Team, AS study directors and internal and external customers.      * Definition, presentation and representation of analytical CMC programmes to customers, potential new customers & external meetings, including oversight of large analytical portfolio projects.      * Design an...
Read more

GlaxoSmithKline (GSK): Esprit Physician Leadership Development Programme

Esprit Physician Leadership Development Programme Are you an MBBS or MD with experience gained in a pharmaceutical, biotech or academic environment eager to become an outstanding leader? An inquisitive mind who would thrive on a diverse, intellectually demanding global leadership programme? Do you want to translate your medical expertise into disease-beating medicines? And help people across the world to do more, feel better and live longer? We are a science-led, global healthcare company that puts patients first. Our business is focused on developing medicines that improve the quality of human life. To meet the future strategic challenges this entails, we need to fast-track the finest medical talent into senior leadership roles within our business. The Esprit Physician programme is an initial three-year, accelerated, multi-disciplinary and individually tailored programme. It is heavily backed by our senior management team, and it will give you incredible standing as a phys...
Read more