Scientist - Analytical Operations - II*

The Fountain Group; Oceanside (CA); On-site; USD 62,000 - 69,000; Full time

Job summary

The Fountain Group is seeking an Associate Scientist, Purification Process Development, to join our team in Oceanside, CA. This onsite role supports purification process development for pivotal and commercial biologics with a focus on lab-scale experiments, technology evaluation, and successful technology transfer to GMP facilities.

Qualified candidates will have advanced degrees with 2+ years (MS) or 4+ years (BS) of relevant experience, strong data analysis, ELN documentation, and hands-on

Qualifications

• MS in Chemical Engineering, Biochemistry, Bioengineering, Biotechnology, or related field with 2+ years of relevant experience.
• BS in a related discipline with 4+ years of relevant experience.

Responsibilities

• Execute purification process development and process characterization studies for pivotal and commercial biologics development.
• Design and perform lab experiments for purification process development, scale-up, and technology evaluation.
• Support process transfer and implementation at GMP facilities.
• Analyze data and prepare protocols, technical reports, and ELN documentation.
• Provide technical support for manufacturing investigations.
• Support purification platform development and new purification technologies.
• Maintain purification lab operations and support GMP/non-GMP drug substance manufacturing activities.

Skills

Biologics purification

Purification process characterization

Chromatography

TFF

NFF

Centrifugation

High-throughput purification

Virus inactivation/removal

Process scale-up

GMP transfer

ELN

GMP/non-GMP processing

Education

MS in a relevant science

BS in a relevant science

Tools

AKTA

UNICORN

JMP

Spotfire

Job description

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