Sr. Manager/Associate Director, Drug Substance Manufacturing

Who you are

You have a strong background in drug substance development and manufacturing, with experience managing outsourced activities at contract suppliers. Your expertise includes process validation and tech transfer, ensuring a seamless commercial supply chain throughout the product lifecycle. You are adept at navigating regulatory requirements and have a proven track record of supporting global marketing authorization applications. You thrive in collaborative environments and are passionate about advancing biopharma innovations for patients with unmet needs.

Desirable

Experience in managing multiple contract manufacturing organizations (CMOs) and contract research organizations (CROs) is a plus. Familiarity with the regulatory landscape and health agency interactions will enhance your ability to succeed in this role. You are a problem-solver who embraces challenges and is motivated by the opportunity to make a significant impact in the biopharma industry.

What you'll do

In this role, you will oversee the management of outsourced drug substance manufacturing activities, ensuring that all processes meet the highest standards of quality and compliance. You will coordinate with various CMOs and CROs to deliver bulk starting materials and manage the manufacture of raw materials and drug substances for commercial launch. Your responsibilities will also include leading process validation efforts and facilitating tech transfers to new vendors, ensuring that the commercial supply chain is robust and efficient.

You will play a critical role in supporting the submission of global marketing authorization applications, working closely with regulatory teams to address health agency queries and ensure timely responses. Your ability to manage multiple projects simultaneously will be essential as you navigate the complexities of drug development and manufacturing.

What we offer

BridgeBio offers a competitive salary range of $173,060—$210,980 USD, reflecting your experience and expertise in the field. You will have the opportunity to work alongside some of the most respected minds in the industry, contributing to groundbreaking advancements in rare disease treatments. We foster a culture of innovation and collaboration, empowering our team members to push boundaries and redefine the future of biopharma. Join us in our mission to develop life-changing medicines for patients with unmet needs.