Associate Director, Drug Substance Scientist

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Requirements:

• Education: PhD or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• 8+ years of relevant industry experience.
• Extensive experience in downstream drug substance process development for biologics, particularly antibodies.
• Experience with upstream process development is highly preferred.
• Track record of successful technology transfers and scale-up to cGMP manufacturing.
• Experience with late-stage development and regulatory submissions.
• Strong knowledge of antibody purification technologies and quality control measures.
• Familiarity with QbD principles and risk-based process development.
• Proficiency in data analysis and process modeling tools.
• Strong problem-solving and communication skills.
• Ability to work in a fast-paced, dynamic startup environment.

Responsibilities:

• 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 and filtration for antibodies.
• Design, plan, and execute Process Performance Qualification (PPQ) activities.
• Oversee transfer of processes to manufacturing facilities and ensure regulatory compliance.
• Collaborate with analytical teams to define critical quality attributes and ensure process consistency.
• Author and review regulatory filings related to drug substance processes.
• Provide technical leadership and mentor junior scientists, promoting a culture of innovation and improvement.