CMC (small molecule) Head

Responsibilities:

RESPONSIBILITIES
• Plan and lead Drug Substance and Drug Product development via contract research and contract development manufacturing organization (CDMO) partners, from pre-clinical through clinical development to ensure uninterrupted drug supply manufactured within GMP compliance.
• Ideally the position will also help define robust and scalable synthetic methodologies for drug substances, or formulation development.
• Scope includes pre-formulation, formulation development, analytical method development and transfer, process development, optimization, scale-up studies/technology transfer, clinical manufacturing, and stability.
• Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early stage programs. Negotiate and obtain legal and corporate approval for service agreements and related statements of work for development activities with external partners.
• Collaborate with cross-functional team and external partners to deliver robust, scalable, and cost-effective manufacturing processes and drug product formulations that meet or exceed clinical target product profile on one or more programs
• Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products, initially in clinical trials. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to all manufacturing operations
• Participate in product development project teams as CMC functional area representative. Actively manages CMC projects, creating and providing comprehensive plans, project analysis, and status reports/dashboards to teams and senior management as required
• Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc.
• Work with Regulatory, QA and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations
• Support creation and/or review of CMC sections of regulatory submissions (i.e. IMPD/INDs/NDA), and responses to regulatory agency (i.e., FDA, EMA, etc.) questions.

Qualifications:

• PhD or MS in a relevant discipline
• A minimum of 10 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing within the pharmaceutical industry
• Experience with late stage development (e.g phase 2, 3, NDA) CMC desired.
• Technical expertise in process development, scale-up, analytical characterization and stability of oral solid, small-molecule, poorly soluble compounds.
• Hands on experience in product development including oral tablet drug products.
• Strong understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions
• Excellent project management and leadership skills, with ability to lead multiple programs at the same time
• The ability to communicate in Mandarin would be a strong plus