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Research Associate - Purification Process Development

Marin Metro Area, California

Post Date: 07/19/2017 Job ID: JN -072017-19574 Industry: Biochemistry- Scientific
DUTIES:
  • 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.

REQUIRED SKILLS:
  • At least two years previous experience in biological process development or related biopharmaceutical job function desired.

DESIRED SKILLS:
  • 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

EQUIPMENT:
  • 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
  • HPLC/UPLCs
  • 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
  • Pumps
  • Compressed gas cylinders/regulators

EDUCATION:
  • Master s degree in Biochemistry, Chemical Engineering or related field.
  • BA or BS will be considered.


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