Scientist - Analytical Operations - II*

The Fountain Group is currently seeking a Associate Scientist, Purification Process Development for a prominent client of ours. This position is located in Oceanside, CA. Details for the position are as follows:

Associate Scientist, Purification Process Development
Location: Oceanside, CA – Onsite 5 days/week
Pay Rate: $45.28/hour
Duration: 1 year

Job Description

• Execute purification process development and process characterization studies supporting pivotal and commercial biologics development.

• Design and perform laboratory experiments for purification process development, scale-up, and technology evaluation.

• Support process transfer and implementation at internal and external GMP manufacturing facilities.

• Analyze experimental data and prepare protocols, technical reports, and electronic laboratory notebook documentation.

• Provide technical support for manufacturing atypical event investigations.

• Support purification platform development, process improvements, and implementation of new purification technologies.

• Maintain purification laboratory operations and support GMP/non-GMP drug substance manufacturing activities.

Education

• M.S. in Chemical Engineering, Biochemistry, Bioengineering, Biotechnology, or related scientific discipline with 2+ years of relevant experience.

• B.S. in a relevant scientific discipline with 4+ years of relevant experience.

Required Skills

• Biologics purification process development

• Purification process characterization

• Chromatography

• Tangential Flow Filtration (TFF)

• Normal Flow Filtration (NFF)

• Centrifugation

• High-throughput purification screening

• Virus inactivation and removal

• Process scale-up

• GMP process transfer and implementation

• Purification process operations

• Experimental design and data analysis

• Electronic Laboratory Notebooks (ELN)

• GMP and non-GMP drug substance processing

Preferred Skills

• AKTA chromatography systems

• UNICORN software

• JMP

• Spotfire

• Design of Experiments (DOE)

• Lab automation

• Data management and data science

• Knowledge management

• Pivotal-stage purification development

• Purification process implementation in GMP facilities

• Purification platform development and technology evaluation

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