Principal Drug Substance Scientist - Remote

Overview

The Principal, Drug Substance Scientist will play a pivotal role in the development, scale-up, and optimization of antibody manufacturing processes, ensuring the highest standards of quality, efficiency, and regulatory compliance.

In Short

• Lead the development, optimization, and scale-up of upstream and downstream processes for antibody drug substance production.
• Collaborate with cross-functional teams to integrate upstream and downstream workflows seamlessly.
• Develop and optimize purification processes, including chromatography, filtration, and other separation technologies for antibodies.
• Establish scalable and robust downstream processes to ensure high yield and purity of drug substance.
• Design, plan, and execute Process Performance Qualification (PPQ) activities to support late-stage upstream and downstream process validation.
• Ensure process robustness and consistency through statistical analysis and data-driven approaches.
• Oversee the transfer of processes to manufacturing facilities, ensuring alignment with regulatory requirements and commercial scalability.
• Collaborate with analytical development teams to define critical quality attributes (CQAs) and establish in-process controls.
• Author and review sections of regulatory filings related to drug substance processes.
• Provide technical leadership to the team and mentor junior scientists and engineers.

Requirements

• PhD or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of relevant industry experience.
• Extensive experience in downstream drug substance process development for biologics, specifically antibodies.
• Experience with upstream process development is highly preferred.
• Proven track record of successful technology transfers and scale-up to cGMP manufacturing.
• Strong knowledge of antibody purification technologies and quality control measures.
• Familiarity with QbD (Quality by Design) principles and risk-based process development.
• Proficiency in data analysis and process modeling tools.
• Strong problem-solving and decision-making skills.
• Excellent communication and collaboration abilities.
• Proven ability to work in a fast-paced, dynamic startup environment.

Benefits

• Opportunity to work with state-of-the-art technology.
• Chance to contribute to the development of an innovative pipeline.
• Dynamic and fast-growing team environment.
• Remote work flexibility within the United States.
• Culture of innovation, collaboration, and continuous improvement.