Scientist - Process Development

Advaxis, Inc. Princeton , NJ 08544

Posted 3 months ago

Overview

Advaxis is a growing clinical-stage biotechnology company developing cancer immunotherapies based on its proprietary platform that redirects the immune system to identify and destroy cancer cells.

We are seeking an individual with technical experience in process development and process analytical development of biotechnology products. This individual will provide perform experiments for the design of the manufacturing processes, technology transfer, process validation, and new product commercialization. This individual will also support the ongoing development and GLP/GMP manufacturing/testing activities.

Responsibilities

Be responsible for, with minimal oversight, the execution of WAVE fermentation, tangential, flow filtration, lyophilization and stability experiments for early stage development, transfer and validation of processes and assays to internal and external CMO sites.

Provide technical support for multiple areas including process engineering, manufacturing and quality support, process/assay troubleshooting, technology transfer, continuous improvement, technical investigations, product characterization/comparability, and validation.

Supports development activities related to microbial fermentation, purification, drug product formulation/delivery systems, stability/hold times, container closure, in-use stability and product/process characterization and packaging/distribution.

Establishes scalable, robust, and streamlined WAVE fermentation and filtration processes using statistical process control, data mining, and other operational excellence methodologies.

Identifies technologies and tools needed to increase the throughput of the development/pilot labs and reduce costs. Support continuous process improvement initiatives.

With minimal oversight designs, executes, and documents lab and pilot scale studies to generate process knowledge in support of creating robust platform processes and defining CPPs/CQAs. Author SOPs and technical development reports.

Qualifications
3-5 years of process development experience with therapeutic proteins or vaccines.

Strong understanding of engineering, cell biology, immunology, or related scientific fields with in-depth knowledge of drug development and manufacturing processes/assays for parenteral biopharmaceuticals.

Demonstrated skills in problem solving, verbal/written communication, and personnel management.

Hands-on experience with GLPs/GMPs, risk-based approaches, QbD, design of experiments, and scientific knowledge management. Experience with GE WAVE and TFF.

Strong understanding of engineering, cell biology, immunology, or related scientific fields with in-depth knowledge of drug development and manufacturing processes/assays for parenteral biopharmaceuticals.

Ability to travel up to 10%


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Scientist - Process Development

Advaxis, Inc.