Johnson & Johnson Careers
Associate Director, Small Molecule
Requisition ID: 1805652309W
· Oversee analytical activities for the R&D and JSC portfolio at CROs located in China (primarily Wuxi, Pharmaron, but not limited to these CROs).
· Provide analytical technical guidance and trouble-shooting support to analytical teams in CRO and other external partners. Review technical documents (protocols/reports) from CRO to ensure GMP compliance.
· Ensure cGMP compliance in all aspects of activities performed at CROs, where relevant.
· Track performance and provide reports on metrics to Management.
· Seek creative approaches to improve the accuracy, reliability, flexibility and productivity of the analytical development activities in China.
· Broad and strong scientific analytical chemistry knowledge in the CMC field, which includes but not limited to analytical method development and validation, GMP release testing, stability study for both API and Drug Product.
· Strong interpersonal skills to effectively communicate with external sites and various internal and external functional areas.
· Good understanding of global Regulatory requirements and ability to respond as to authority questions.
· Ability to prioritize and balance compliance with business needs.
· Strong leadership skills. Management experience is a plus.
· Master’s degree in Chemistry, Pharmacy or equivalent with excellent knowledge of analytics, stability and specs. PhD in same fields preferred.· At least 8 years of senior level industry experience in global, medium-size pharmaceutical development or research entities or CRO.
Languages· Language requirement: English / Chinese
J&J (China) Investments Ltd (7046)