The Director, CMC and Technical Operations is responsible for managing the drug substance and drug product development, manufacturing, and validation activities of small molecule drugs at the CDMOs, serving as a technical subject matter expert. This position collaborates closely with colleagues in Discovery Research, Regulatory, and Quality, supporting the corporate goals for preclinical and clinical development of novel molecule glue drugs.

Responsibilities:
61 Provide Technical oversight of the manufacturing and scale up of DS and DP at CDMOs for preclinical and studies.
61 Provide technical review and approval for manufacturing related documents including tech transfer, process development, specifications, stability protocols, batch records, and validation protocols/reports.
61 Verify suitability, qualification, and validation of technical staff and processes at CDMOs and other external laboratories.
61 Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
61 Provide CMC development and manufacturing support on internal and external project teams.
61 Maintain up-to-date knowledge of China, US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
61 Author and review CMC sections of regulatory submissions.

Education/Experience Requirements:
61 PhD in Chemistry, Chemical Engineering, or other related discipline.
61 Minimum 8+ years of relevant experience including small molecule manufacturing, scale-up, and drug development.

Additional Skills/Experience:
61 Expertise in novel small molecule drug substance manufacturing process and phase appropriate CMC strategy.
61 Manufacturing experience with drug product development a plus.
61 Demonstrated ability in managing CDMOs.
61 Expert knowledge in process development, validation, and technology transfer procedures.
61 Strong professional experience in a similar role within the pharmaceutical industry, preferably in small biotech companies.
61 Broad knowledge and experience within the GMP environment and regulatory affairs.
61 Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
61 Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
61 Strong interpersonal and organizational skills and excellent verbal and written communication skills in Chinese and English are required.
61 Excellent decision-making and collaboration skills with strong attention to detail.