Director, CMC

Location
92130, San Diego
Posted
Feb 16, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time

HUYA Bioscience International is a development-stage biopharmaceutical company bringing innovations from China to global markets in multiple therapeutic areas. The Company’s lead cardiovascular program, HBI-3000, recently started a phase 1 in Europe and HUYABIO’s partner in China has run multiple phase 2 trials there. HUYABIO’s lead compound in oncology, HBI-8000, is in late stage clinical development in Japan and Korea for the treatment of hematological malignancies. In the United States, HBI-8000 is being developed in combination with immune checkpoint inhibitors in solid tumors. Two additional compounds are in early evaluation for oncology and cardiovascular diseases. More information can be found at www.huyabio.com
 

Job Summary
HUYABIO is seeking a self-motivated, goal-oriented individual to take an active role as Director, CMC. The Director, CMC, will report to the SVP, CMC. Responsibilities include but are not limited to, lead the process development, manufacture, release and stability of portfolio drug candidates with a particular focus on drug substance and analytical activities. Assist in the technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations. Manage drug candidate supply chain by efficient manufacturing planning, maintenance of inventory and distribution of clinical trial material in support of studies in all territories.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and global office sites is essential.
 

Primary Duties and Responsibilities
• Lead the process development, manufacture, release and stability of portfolio drug candidates with a particular focus on drug substance and analytical activities
• Assist in the technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations in an out-sourced operating model
• Manage drug candidate supply chain by efficient manufacturing planning, maintenance of inventory and distribution of clinical trial material in support of studies in all territories.
• Evaluate third-party manufacturers working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply/technical agreements and scopes of work.
• Identify and manage contract analytical laboratory site(s) required to guide and support third party manufacturing relationships
• Design and oversee execution of necessary DOE and process development activities in preparation for Registration and Validation activities.
• Assist in the management and execution of IND enabling activities in preparation for regulatory filings
• Author relevant sections of regulatory documents, including Investigator’s Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
• Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations.
• Participate in product development project teams as CMC functional area representative
• Track proposals and invoices to insure alignment with approved CMC budget
• Manage consultants, vendors, and CROs to meet agreed upon program timelines/budgets
• Perform other duties as required

Job Requirements
• Fluent in written and spoken Chinese (mandarin), ideally with experience of working with China based CMOs
• Strong knowledge of current US and EU regulations and cGMPs
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication
• Strong cross-functional team experience
• Demonstrates strong problem‐solving and leadership skill-sets
• San Diego-based position
• International experience is a plus
• Travel, as needed

Education and Experience
• BS degree in a scientific/engineering discipline
• M.S. degree or Ph.D. Degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
• 10-15 years of experience in the pharmaceutical/biotech industry
• 8+ years’ experience in small molecule drug substance process development/manufacture and analytical methodology development/validation
• 5+ years of experience in pharmaceutical development of small molecules drug candidates
• 5+ years of experience in formulation/process development of poorly soluble drug candidates
• Authored CMC sections of regulatory filings for US, Europe, or Asian markets

The position is full‐time and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters. Interested candidates should submit resumes to: recruit@huyabio.com.
To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity employer.