工作地点:上海

Responsibilities

• Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies

• Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of pipeline programs

• Develop and implement strategy and DOE (design of experimentation) for optimizing, characterizing, and controlling quality of bulk API and DP using CROs and CMOs

• Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet the target preclinical and clinical profile

• Projection of API and DP needs for preclinical and clinical programs and associated budgets

• Formulation design/development for preclinical and clinical programs

• Management of supply chain and logistics in support of clinical studies

• Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards

• Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations

• Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before U.S., European, and China regulatory authorities

• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents

Qualifications:   

• Substantial experience in managing CRO/CMOs for the manufacture of cGMP APIs and DP

•  Experience with projects in clinical development including multiple pharmaceutical dosage forms (e.g. tablets, capsules, etc.)

• Experienced with cGMP manufacturing and IND filings; thorough knowledge of relevant FDA and NMPA regulations  

• At least 5 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment

• Experience in supply chain management.

• PhD or MS with 5+ years of experience; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline

• Able to identify and resolve critical issues

• Experience implementing technical, strategic and operational plans

• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)

To apply, please send your CV to hr@eccogene.com, or click the button below to apply online.