锦鲤求职岗位描述
【Key Responsibilities】
<p>Design and oversee critical CMC studies for external project evaluations, ensuring robust experimental planning and data interpretation.</p> <p>Manage and coordinate interactions with CROs, including study design, execution oversight, and results assessment to ensure material planning to meet timeline and quality requirement.</p> <p>Work cross-functionally with internal teams (medicinal chemistry, biology, DMPK, toxicology, regulatory affairs, clinical development) to support CMC activities from preclinical candidate (PCC) selection to Phase 1/2 clinical trials.</p> <p>Lead internal and external collaborations to ensure smooth progression of CMC activities, optimizing formulation development and manufacturing processes.</p> <p>Provide guidance on pre-formulation and regulatory CMC requirements to ensure compliance with industry and regulatory standards.</p>
【Qualifications】
<p>PhD in pharmaceutical science or related discipline.</p> <p>At least 3 years of industry experience in CMC development within a pharmaceutical or biotech company; candidates from relevant CRO backgrounds will also be considered.</p> <p>Strong expertise in small molecule drug development, formulation sciences, and regulatory CMC guidelines. Experience managing cross-functional collaborations and external CRO partnerships.</p> <p>Excellent communication, leadership, and project management skills.</p> <p>Ability to navigate and conduct preliminary bench experiment to solve preform issues.</p>