Research Associate - Purification Process Development
Marin Metro Area, California
- Develop and optimize purification processes for pre-clinical and clinical trials and commercial production of biological drug candidate molecules.
- Produce candidate molecules for pre-clinical research.
- Transfer developed purification processes to manufacturing groups.
- Work includes cross-functional interaction and support for other groups, including Manufacturing, Quality, Validation, Research, Pharmacological Sciences and others.
- Knowledge of protein purification, enzymes, enzyme kinetics a plus.
- Knowledge of protein/enzyme quality attributes, quality indicating assays and assay development a plus.
- Experience with the use of statistical methods to plan and execute multi-variable experiments a plus. Use of related methods to evaluate risk a plus.
- Provide quantitative analysis of data and interpretation of results.
- Record experimental data and analysis in lab notebooks. Write protocols. Write or contribute to technical reports and other documents (e.g., process validation, batch records).
- Evaluate complex lab equipment; recommend vendors. Provide assistance to manufacturing start-up, troubleshooting and validation.
- At least two years previous experience in biological process development or related biopharmaceutical job function desired.
- Basic protein/enzyme skills, including (not limited to):
- Large and small scale purification by chromatography, tangential-flow filtration, and related methods
- Analytical methods for the determination of protein/enzyme quality attributes.
- Knowledge of the basics of analytical assay development and qualification
- Assessment of protein/enzyme stability and knowledge of formulation techniques
- Chromatography columns and controllers at various scales (1 35 cm column i.d.).
- Controllers include AKTA bench top units (AKTA Pur, AKTA Avant, Unicorn software) and larger scale units
- Ultrafiltration/Diafiltration equipment for concentrating and diafiltering various volumes (generally several mL to several L, but occasionally up to 1000 L.
- Fluorescent / UV/Vis plate readers and spectrophotometers
- Liquid handlers
- Compressed gas cylinders/regulators
- Master s degree in Biochemistry, Chemical Engineering or related field.
- BA or BS will be considered.