Lonza: Study Director

Lonza Analytical Services is the provider of choice for high value analytical services to the biopharmaceutical industry; its capabilities and expertise encompasses a wide range of technologies to support all stages of production and process development. Analytical Services offer Product Characterisation, Stability and Analytical Method Development & Validation studies and employs an extensive range of technologies including HPLC, UPLC, gel electrophoresis, icIEF,

qPCR and immunoassay.

The Study Director will be joining the Analytical Services team at an exciting time as the department moves into a brand new, purpose built analytical laboratory and offices in Q3 2013.

Role overview:

To provide activity/potency methods in support of process and product development and manufacture for antibodies and other recombinant proteins being manufactured by Lonza Biologics.

Responsibilities:

• Scheduling and prioritisation (with input from appropriate management) of studies and resources for on time delivery of development, qualification and validation studies.

• When required lead junior scientists / technologists in the development and transfer of potency assays from customers.

• Liase with customers to ensure efficient and successfully transfer of activity/potency assays into Lonza Biologics laboratories.

• Writing and Review of Study Protocols and Reports for Assay Qualification and Valiadation studies and ensure that

studies are delivered to the appropriate scientific and technical quality.

Experience:

- Considerable experience in the development and validation of analytical methods for recombinant protein therapeutics.

- Demonstrated experience of development and validation of ELISA and Bioassay technniques for activity/potency testing

of recombinant proteins.

- Proven ability in working with and presenting to customers on a variety of scientific subjects.

- Proven ability to deliver analytical programs to agreed timelines and resource plans.


REQUIRED SKILLS:


Life sciences MSc/PhD or equivalent experience.

Experience of working for a contract research manufacturing organisation preferred.

Lonza promotes a fast-paced, employee orientated environment and we take pride in both the quality of our products and the success of our employees. We offer a competitive remuneration package and encourage the development of

individuals to help them achieve their full potential.

If you are interested in this opportunity please apply online via our careers page. Please ensure that you attach your CV to your profile.

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