Process Development Associate II
BioPhase Solutions - San Diego, CA

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BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Process Development Associate II to work for a leading San Diego biotechnology company.

Process Development Associate II

Experienced Process Development Associate will be responsible for setting up and executing bench-scale experiments to characterize manufacturing processes involving production of bulk plasmid DNA to prepare for process validation runs and subsequent BLA filing. The Process Development Associate must have the ability to follow protocols and batch documents with accuracy and a high attention to detail; must be capable at switching projects between upstream and downstream processes when necessary. The Process Development Associate will work with scientists, engineers, operators, and other associated groups to characterize processes and to help troubleshoot any process-related problems. He or she will execute scale-down, hold time, and lifetime studies, in addition to process characterization (DoE) studies as needed.

Execute scale-down experiments to characterize manufacturing processes.

Identify critical process parameters and determine acceptable ranges to control the processes and optimize performance.

Write protocols, execute experiments, analyze data, and write study reports to document results and to support Regulatory filings.

Interact with Manufacturing, Engineering, QC, QA, and other departments as needed to accomplish company objectives.

Job Knowledge and Experience

Knowledge of fermentation and/or standard recovery and purification processes for biologic products including ultrafiltration and chromatography (AKTA knowledge a plus),

Familiarity with ICH guidelines, Quality-by-Design (QbD) principles, and Design of Experiments (DOE) techniques to characterize and validate manufacturing processes,

Strong interpersonal and communication skills, both verbal and written, and the ability to work effectively in a team-oriented environment,

Ability to plan ahead organizes and prioritizes workload, coordinate activities with other groups, and meet project deadlines.

A Bachelor’s degree with 2 to 5 years of experience in Chemical or Biochemical disciplines. Candidates must have experience in a process R&D function.

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