San Mateo Metro Area, CA
Looking for an energetic and talented individual to join our Formulation and Analytical Development team. The primary responsibility for the incumbent will be to support the developmental activities currently on going in the laboratory through the management and undertaking of key stability indicating assays, primarily the bioassay which supports both product dose and the key stability indicating endpoint. This assay uses nephelometry as the analytical measurement tool and it will be used to assess both drug substance (DS) and drug product (DP) concentration and stability. Other aspects that require development are monoclonal based ID tests and to perform the characterization of these monoclonal themselves.
- PhD with >3 years in Chemistry or Analytical Chemistry preferred, Organic / Biochemistry considered OR
- BSc or MSc with >6 year of industrial experience
- Extensive monoclonal based bioassay experience:
- in both the development, optimization and pre-validation/validation of said assay(s).
- Of notable interest:
- Prior nephelometry experience.
- Prior vaccine experience where the system contained aluminium or other adjuvants
- Experience in:
- Use and programming of automatic liquid handling systems is preferred, particularly BioMek systems
- Developing suitably robust bioassay methods and execute transfers to external CMOs would be preferable
- Characterization of mAbs for use within the early clinical trial assays would be preferable
- Chemical/biological/immunological assays such as Dot Blot, HPLC, UV and other spectrometric methodologies are welcomed
- Working within teams to support stability studies, including sample co-ordination and timely data output
- Attention to detail and excellent skills in record keeping / documentation. Critical thinking and ability to analyse data
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats
- Ability to work under supervision in a fast-paced, cross-functional environment and collaborate effectively with other team members. Eagerness and ability to learn and understand new concepts with ease