Job Description

Primary Function:

The successful candidate is expected to take a leadership role to manage and lead the company’s CMC (Small Molecule and Biologics) development and manufacture functions. In this role, the candidate will be responsible for setting the company’s CMC development strategies from early development projects to commercialization products in the context of company’s pipeline growth. The activities will include but not limited to process/formulation development, scale-up, technology transfer, process validation/verification, IND/BLA/MAA CMC filing section preparation, manufacturing tech transfer, CDMO vendor selection, etc. The candidate will be required to spend sufficient working time in China. He/she may be taking the lead to set CMC regulatory strategies for company’s portfolio per requirement.

Major Responsibilities and Duties:

• Manage and lead the CMC organization to ensure team success in achieving the corporate goals and strategies.
• Develop CMC development strategies for the company’s pipeline from early development projects to commercialization.
• Be fully responsible for daily operation and management of CMC department, including safety. Work with Quality Control and Senior Management to ensure that all company policies are adhered to, and all external manufacturing activities comply with relevant regulations.
• Work closely with internal (preclinical and clinical development, regulatory, project management, finance, and other relevant departments) and external partners to actively manage regulatory submission (IND, NDA/BLA/MAA, Post-Approval Amendment, etc.) and interaction, and prepare relevant products for launch.
• Serve as the technical experts to direct and oversee CMC development and manufacturing activities. Utilize expertise in process development and related scientific disciplines to investigate, troubleshoot and resolve issues that arise during the manufacturing for both R&D and commercial supplies.
• Lead/manage the external vendor selection by collaborating with other departments based on company’s SOP. Manage and oversee the internal and external CDMO manufacturing operations to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support agency inspections internally or externally.
• Take budgetary and organizational responsibilities for the function.
• Participate in external asset evaluations in relevant aspects.
• Responsible for the training and performance appraisal of CMC personnel.
• Other tasks assigned by the supervisor.

Qualifications:

• Doctoral degree or above, at least 8 years CMC project management experience in pharmaceutical or life science, at least 5 years team management experience.
• Have a broad understanding of all aspects of CMC, including process development, regulatory and quality requirements, analytical development, formulation, and drug technology, etc.
• Have rich experience in managing Chinese and global innovative pharmaceutical projects.
• Experience in GMP production and IND and NDA/BLA/MAA declaration. Familiar with FDA, EMA and China NMPA as well as other regulatory agencies requirements and guidelines relating to CMC-related areas.
• Good interpersonal and communication skills, able to establish good relationship with senior management and all levels of the organization.
• Ability to operate effectively in an entrepreneurial and science-driven corporate environment. Self-motivated, result-oriented, and able to motivate others with good conduct and highest ethical standards.
• Experience in managing teams, budgets and resources, and project management skills.
• Ability to think strategically in a complex business environment and deal with ambiguity.

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