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. At Hummingbird Bioscience, the commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic.

For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird Bioscience on LinkedIn, X (formerly Twitter), and YouTube.

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. Serving as an individual contributor, the role focuses on the coordination CMC development activities related to the clinical program(s) and timely supply of clinical materials through the development phases. The candidate will contribute to the success of clinical programs by keeping detailed plans and having a keen awareness of functional technical capabilities.

Responsibilities will include (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.


• 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. PMP certification is a plus.


• Excellent interpersonal skills with the ability to build relationships across internal and external partners in a global environment.


• Experience with CDMO management a plus


• Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up 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.

JOIN US AT THE FRONTIER OF DRUG DISCOVERY AND DEVELOPMENT

We are looking for passionate and motivated individuals committed to solving important, complex problems. We are committed to the personal and professional development of our team and offer robust learning and development programs. Hummingbird Bioscience understands the need for flexibility for our team and offers a generous paid time off program with flexibility to support employees through different life stages. We invest in our team’s health by offering competitive benefits including health and dental insurance, and a comprehensive and holistic employee assistance program. We foster a more collaborative, productive, and sociable culture with on-site lunches and snacks. Finally, we believe in creating social impact beyond our business through corporate social responsibility initiatives.

Are you ready to join us on our mission to discover and develop important new drugs for cancer and autoimmune disease? Click on ‘Apply for this Job’ to submit your application.

For further enquiries, please email us at [email protected].

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.