HUYA is seeking a self-motivated, goal-oriented individual to take an active role as Director, CMC. The Director, CMC, will report to the VP, 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 HUYA 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
- 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. 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 Primary/Registration 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
- 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 of experience in pharmaceutical development of small molecules drug candidates
- 5+ years’ experience in small molecule drug substance process development/manufacture and analytical methodology development/validation
- 5+ years of experience in formulation/process development of poorly soluble drug candidates
- Authored CMC sections of regulatory filings for US, Europe, and Japan