Sr. Manager, Commercial Manufacturing Operations

Who you are

You have a strong background in commercial manufacturing operations, particularly in the biotech or pharmaceutical industry. With at least 5 years of experience, you have developed a deep understanding of process chemistry and chemical engineering, allowing you to lead technical discussions and decisions effectively. Your experience includes managing relationships with contract manufacturing organizations (CMOs) and regulatory starting materials (RSMs) suppliers, ensuring that all manufacturing activities align with regulatory standards and company goals.

You thrive in a collaborative environment, working closely with cross-functional teams to drive projects forward. Your ability to communicate complex technical concepts to non-technical stakeholders is a key strength, enabling you to bridge gaps between different departments. You are detail-oriented and possess strong problem-solving skills, allowing you to navigate challenges that arise during the manufacturing process.

Desirable

Experience in the biotech industry is highly desirable, particularly with small molecule APIs. Familiarity with regulatory requirements and quality assurance processes will set you apart. You are also comfortable with documentation review and quality event support, ensuring that all aspects of manufacturing meet the highest standards.

What you'll do

In this role, you will serve as the technical lead for small molecule API CMOs and RSM suppliers, overseeing all aspects of manufacturing from raw material ordering to the release of APIs. You will be responsible for managing the technical transfer process, including process validation activities, to ensure that all manufacturing processes are efficient and compliant with regulatory standards. Your role will involve close collaboration with various CMC functions, ensuring that all teams are aligned and informed throughout the manufacturing process.

You will also be tasked with reviewing documentation related to manufacturing activities, providing support during quality events, and ensuring that all processes are well-documented and compliant with industry regulations. Your leadership will be crucial in driving continuous improvement initiatives within the manufacturing operations, helping to enhance efficiency and reduce costs.

What we offer

BridgeBio offers a competitive salary range of $161,100 to $183,310 USD, reflecting the importance of this role within our organization. You will have the opportunity to work alongside some of the most respected minds in the industry, contributing to groundbreaking advancements in rare disease treatment. We foster a culture of innovation and collaboration, encouraging you to push boundaries and redefine what is possible in biopharma. Join us in our mission to develop life-changing medicines for patients with unmet needs.