Director CMC Operations


Chemistry, Manufacturing and Controls Department

Report to: CEO 



MAIN RESPONSIBILITIES:

 

Director of Chemistry Manufacturing and Controls is responsible for providing overall leadership for CANbridge Chemistry Manufacturing and Controls in the successful transfer of processes from Europe and the U.S. to China. Coordinate and manage the CMC activities in plan development and execution to ensure the implementation CMC life cycle management program. Drive CMC development launch activities, including CMO (contract manufacturing organizations) selection and technology transfer for bulk drug substance and finished product from licensor to CMOs.

Specifically,

Represent all manufacturing OPS functions to senior management.

Manage partnering programs and general support of the product through continuous improvement initiatives.

Oversee planning and budget development, capacity forecasting, sourcing, and management of CMOs and CANbridge licensors to ensure drug substance, bulk drug product, finished dosage form and related packaging operations are performed in compliance with CFDA GMP requirements.

Represent CANbridge manage and coordinate inquiry and fulfilment of CMC-related requirements by CFDA/FDA/EMEA. Lead the planning and supply chain group to ensure supplies of investigational and commercial bio/drug product are sufficient to support clinical trials and commercial activities.

Coordinate manufacturing investigations, and assist in troubleshooting analytical or production deviations. Monitor and act promptly to address process and product quality trends and issues.

Partner with all relevant functions to align on strategy for a regional drug supply network.

 

 

EDUCATION AND EXPERIENCE


Minimum MS degree in pharmaceutical formulation or related scientific or chemical engineering field and extensive relevant industry experience.

A minimum of 15 years relevant pharmaceutical, manufacturing experience including GMP biologics CMC development in the pharmaceutical industry.

 

SKILLS AND KNOWLEDGE:


Extensive experience (15 years+) with leading CMC teams or other related cross functional teams that require program leadership within a matrix environment including CMC development knowledge, solid understanding of the registration processes.

In-depth technical experience in a relevant biopharmaceutical development discipline.

Knowledge in non-GMP and GMP process development of biologics manufacturing, and associated unit operations and regulations.

Strong project management and Chinese and English communication skills including managing 3rd party manufacturing sites.

Demonstrated leadership and capability for strategic analysis and problem solving, organizational and project management skills working in a matrix environment.

Strong organizational skill, and excellent communication, negotiation, problem solving and decision making skills.

Must demonstrate the capability and the confidence to examine and mitigate broad risks.

Displays sense of urgency to resolve problems that arise during drug development, such as instability, manufacturing start-up; Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation.

Excellent attention to detail with the ability to apply technical expertise to overall drug development strategy.

Required to spend up to 25% time in China. Availability for business travels.

 

 

About CANbridge Life Sciences

CANbridge Life Sciences, Ltd. is a bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan).  CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses or obtains exclusive rights to commercialize drug and device products that are approved in their home markets for commercialization in China and North Asia.   CANbridge has an exclusive licensing agreement with U.S.-based Azaya Therapeutics, Inc., to develop and commercialize ATI-1123 in China, for the treatment of non-small cell lung cancer and other solid tumors. CANbridge also has an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize lead candidate, onco-immunotherapy, APG101, for the treatment of glioblastoma multiforme in China, Macao and Hong Kong.

Led and backed by a seasoned executive team with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. 


Contact Email:xchen@canbridgepharma.com


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