CMC Project Manager

CMC Project Manager - Hummingbird Bioscience
Full time position – Singapore-based location
ABOUT HUMMINGBIRD BIOSCIENCE
Hummingbird Bioscience is a biotherapeutics company working at the interface of artificial intelligence and human innovation to discover and develop transformative medicines for hard-to-treat diseases. Hummingbird Bioscience’s computational and systems biology technologies have generated a pipeline of innovative clinical-stage monoclonal antibodies and antibody-drug conjugates in oncology and autoimmunity.
About the role
Hummingbird Bioscience is seeking a motivated and well-organized individual to be part of the Chemistry, Manufacturing and Controls (CMC) team as (Senior) Project Manager, CMC. The candidate will report to the VP of CMC and is expected to represent the department in both internal and external interactions as well as serve as a key facilitator amongst various stakeholders.
Responsibilities will include:
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.
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.
Work with technical functions to coordinate and facilitate the timely resolution of regulatory requests and quality issues.
Interface with Program Leads to ensure timely supply of clinical supplies, including detailed planning and status updates.
Oversee contractual obligations and timely execution of plans for external parties.
Communicate expected risks and constraints to stakeholders and senior management.
Core Experience and Qualifications:
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.
Excellent interpersonal skills with the ability to build relationships across internal and external partners in a global environment.
OUR MISSION & VALUES
Our fast-growing biotechnology company is committed to discovering and developing important new drugs for cancer and autoimmune diseases, and living by our values: Excellence, Determination, Teamwork, Intellectual Integrity and Audacity.
Hummingbird Bioscience is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Singapore and US federal, state and local laws and/or guidelines that prohibit employment discrimination on the basis of age, race, color, gender, sexual orientation, gender identity, ethnicity, national origin, citizenship, religion, genetic carrier status, disability, pregnancy, childbirth or related medical conditions, marital status, protected veteran status and other protected classifications.
#J-18808-Ljbffr