Principal, Drug Substance Scientist

About Us

About the Role

As 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.

Reporting to the Senior Director, Drug Substance and MSAT, you will oversee upstream and downstream process development for drug substance production, specifically focusing on antibody-based therapeutics. Day to day, you will lead drug substance manufacturing, manage and troubleshoot all production releases, PPQ, and work alongside internal and external partners. Experience across both upstream and downstream processes is ideal.

This is an exciting opportunity to join a fast-growing and dynamic team. You will have the chance to contribute to the development of an innovative pipeline and work with state-of-the-art technology. We are open to the position being based remotely within the United States. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

     Process Development:

• 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.

     Downstream Expertise:

• 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.

    Manufacturing Expertise:

• 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.
• Prepare and review PPQ protocols and reports for regulatory submissions.

   Technology Transfer:

• Oversee the transfer of processes to manufacturing facilities, ensuring alignment with regulatory requirements and commercial scalability.
• Work closely with CMOs/CDMOs to support late-stage development and commercialization activities.

    Analytical Support:

• Collaborate with analytical development teams to define critical quality attributes (CQAs) and establish in-process controls.
• Ensure consistency in process performance through data-driven approaches and risk assessments.

   Regulatory Compliance:

• Author and review sections of regulatory filings related to drug substance processes, such as INDs, BLAs, or MAAs.
• Stay up-to-date on regulatory guidelines to ensure compliance in all process development activities.

   Leadership and Mentorship:

• Provide technical leadership to the team and mentor junior scientists and engineers.
• Promote a culture of innovation, collaboration, and continuous improvement.

Experience

• Education: PhD or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 8+ years of relevant industry experience.
• Extensive experience in downstream (e.g., chromatography, filtration) 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.
• Experience with late-stage process development and regulatory (BLA) submissions.
• 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.
• High sense of accountability to deliver results and meet timelines.
• Proven ability to work in a fast-paced, dynamic startup environment.