Position Summary
The Associate Director / Principal Scientist of CMC Clinical Supply Chain will be responsible for small molecule CMC projects in terms of quality, quantity, timelines and other logistics for drug substance (DS) and drug product (DP) manufacturing to ensure reliable, compliant, cost effective, and on-time delivery of IMPs (Investigational Medicinal Products) for clinical trials in accordance with all related regulations and policies. Additionally, he/she will be a Person-in-Plant (PIP) to coordinate CMC activities to ensure high quality documentation with cGMP requirements.
Essential Duties And Responsibilities
Communicate with external partners and/or manufacturer sites to manage supply chain activities to meet clinical trial requirement.
Act as Person in Plant (PIP), closely monitor CROs or CDMOs for cGMP manufacturing of DS and DP as well as labelling, packaging and shipping.
Work closely with CMC team to plan DP quantity, generation of contracts and manufacturing sites and coordinate with internal stakeholders, including Clinical Operations, Quality Assurance, Regulatory Affair on any supply chain management related activities to achieve clinical trial milestone.
Coordinate with clinical supply chain to ensure implementation of packaging and labeling strategy including labeling and packaging design for each assigned study in compliance to relevant procedures, SOPs, policies and regulations.
Fully support on clinical operations and CMC teams for auditing and inspection for manufacturing sites including API and DP.
Coordinate with quality team on deviations/CAPA, Batch Record Review and product release.
Manage external vendors to ensure the accurate delivery and other logistics arrangements, as well as documentation maintenance.
Collaborate with customs for import and export clinical trial materials.
Stays abreast and up to date with relevant cGMPs, GCPs, and other regulatory requirements/guidance and ensures study management activities are appropriately aligned.
Solid knowledge and experience in CMC especially drug product and drug substance development, manufacturing, stability and releasing as well.
Other duties may be assigned to meet the needs of the business.
Qualifications:
Master’s degree in chemistry/chemical engineer or related science filed.
5+ years progressive experience in Supply Chain, project management for DS/DP preferably within the biotech, pharmaceutical industry and CROs.
Supply Chain Management or Project manager and Business Development for CMC.
Understanding comprehensive global pharmaceutical regulatory requirements (cGMP, ICH/GDP, GCP).
Hands-on knowledge and experience in clinical supply import/export regulation/policy.
Familiar with clinical supply best practices, IRT systems or other systems for clinical supply chain management.
Excellent written and oral communication skills in both English and Chinese.
Demonstrate a proven track record in working with and managing CROs and CDMOs for pharmaceutical development.
