18 months contract
The contractor will be responsible for both laboratory and non-laboratory activities to support testing of proteins, monoclonal antibodies, and vaccine products.
* Laboratory work may include: preparing labels, accurately vialing aliquots, shipping samples, and sample testing using state-of-the-art analytical test methods and technology used for the testing of biotherapeutic compounds. Documentation of activities to cGMP in an electronic notebook will be a requirement of this role. The contractor will also be responsible for preparing all buffers and reagents associated with test methods as well as instrument setup. The contractor is expected to follow GMP documentation practices and must be familiar with general safety procedure, practices and guidelines. Data integrity is a must.
* Non-laboratory work will include statistical analysis of method validation and transfer data sets, as well as data verification, whilst applying a keen understanding of ICH guidance for qualification and validation. Additional documentation opportunities including co-authoring validation protocols and calculation workbooks are possible. Attention to detail is critical to this role.
* Must be self motivated and have a strong attention to detail. Good communication skills required.
- BS in Chemistry, Bio-Chemistry, or related fields
* Ideally two years of relevant industry experience within a Quality Control or Research laboratory is sought
* Knowledge of Statistics is preferred
* Knowledge of ICH guidelines on qualification and/or validation is highly preferred
* Experience in a GMP environment is highly preferred
* Previous experience with large molecules is preferred
Sthree US is acting as an Employment Business in relation to this vacancy.