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- Oversee the CMC activities of the company under the supervision of the CEO
- Drive the execution of the CMC projects throughs CRO and CDMOs to meet critical timeline and global quality standard.
- Lead the internal development of drug candidates, drug substances and drug products of the company and build the infrastructure and function team to substantiate it
- Collaborate closely with drug discovery team, regulatory team and clinical team to ensure smooth execution of projects
- Represent the company at conferences, meetings, conventions and other events as CMC representative
- Responsible for providing technical leadership and guidance across CMC development disciplines to all outsourced development and manufacturing activities by providing clear objectives for multiple CDMO partners, assess all experimental plans and results, and coordinate future work to achieve desired development and manufacturing expectations
- Scope of technical responsibilities include pre-formulation, formulation development, analytical method development and transfer, process development, optimization, scale-up studies/technology transfer, clinical manufacturing, and stability studies
- Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives, milestones, timelines, resources and budgets
- Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations
- Provide succinct and pertinent communication of program CMC status, priorities and pending activities, verbal and written, across company functional areas and to senior leadership
- Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early-stage programs. Negotiate, obtain and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners
- Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products, and ensure timely clinical drug supply for global trials.
- Actively manages CMC aspects of IND submissions and other regulatory interactions for relevant products in close collaboration with the involved departments. Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- PhD in Pharmaceutics or related disciplines
- 10+ years of experience in pharmaceutical or biotechnology CMC management of development programs
- Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions
- Extensive experience in managing CDMOs in different regions for the manufacture of cGMP drug substance and drug product
- Experienced with cGMP manufacturing and IND filings; good working knowledge of relevant US FDA, EMEA and China regulations
- Proven track record of superior interpersonal and communication skills with ability to develop strong positive relationship with senior management as well as all levels of the organization
- Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
- Proven experience in managing teams, budgets and resources
- Project management skills
- Proven ability for strategic thinking in a complex business environment
- Ability to deal with ambiguity
- Mentorship, innovative thinking, keen industry insight, strong analysis and problem solving
Licence no. 16S8112
