Director, Process Development - Drug Substance

This role is responsible for leading and managing process development activities related to drug substance manufacturing. The Director will oversee the design, development, and optimization of robust and scalable manufacturing processes, ensuring alignment with quality, regulatory, and business objectives.

Key Responsibilities:

Lead and mentor a team of process development scientists and engineers.
Develop and optimize chemical and biological manufacturing processes for drug substances.
Design and execute experiments to evaluate process performance and identify areas for improvement.
Ensure processes are robust, scalable, and compliant with regulatory requirements.
Collaborate with cross-functional teams, including analytical development, formulation, and manufacturing.
Manage project timelines and budgets.
Contribute to the development of intellectual property.

Requirements/Qualifications:

Advanced degree in Chemical Engineering, Biochemical Engineering, or a related field.
Extensive experience (15-20 years) in process development for drug substance manufacturing.
Strong understanding of chemical and biological processes, including unit operations and process control.
Experience with scale-up and technology transfer.
Excellent leadership, communication, and interpersonal skills.
Proven ability to manage projects and teams effectively.
Knowledge of GMP and regulatory requirements.

About the Company:

Amgen Technology Private Limited is a biotechnology company focused on discovering, developing, manufacturing, and delivering innovative medicines to patients with serious illnesses. The company is dedicated to advancing human health through scientific innovation and patient access.