About the role

AI summarised

The CMC Project Manager oversees Chemistry, Manufacturing, and Controls (CMC) activities for semiconductor-related projects, coordinating cross-functional teams to ensure timely delivery of process development, documentation, and regulatory compliance. This role involves planning, tracking, and reporting on project milestones while aligning with technical and quality standards.

BiotechOnsiteCMC Project Management

Key Responsibilities

(but are not limited to): Provide project management for Chemistry, Manufacturing and Control elements for Hummingbird Bio’s pipeline programs which are in clinical studies or are in pre-clinical development.
Management of contract development and manufacturing organizations (CDMOs) for clinical supply from Drug Substance, Drug Product and Final Packaging.
Where required, management of the supply chain for combination trials.
Serve as a point of contact for various stakeholders, including, Regulatory CMC, Quality Assurance, Process Development, Analytical Development when advancing the CMC program through clinical development.

Requirements

BSc.or BEng.
in Biotechnology, Pharmaceutical Sciences, Chemical Engineering or related Biological Sciences Broad familiarity with the drug development process with at least 5 years of relevant experience in process/analytical development or clinical manufacturing Ideally with 2 years of experience in project management for manufacturing, CMC, Process/Analytical Development for Biologics A working knowledge or previous experience, either in the industry or as part of the educational training of process/analytical development and manufacturing for antibodies or other biologics.
Excellent organizational, communication [both oral and written], and interpersonal skills.
Systematic and detail orientated organizing complex plans and addressing issues and risks.