A leading, clinical-stage drug development company is advertising a vacancy for a Formulation, based in Shanghai. The organisation focuses on novel therapies for the treatment of diabetes and CNS disorders.
- Responsible for the project management of pharmaceutical development, including formulation research & development, drug product development, especially the new formulation for lifecycle management etc.
- Manage the formulation and drug product works through external collaboration and on-site monitor the ongoing activities.
- Manage the task and timeline of external resource for formulation development and drug product development.
- Review related documents including plan, protocol, batch record, progression report and summary report from external partner.
- Assist and execute formulation development and technology transfer activities at CDMO.
- Prepare the plan, protocol, progression report, and summary report etc. internally.
- Conduct development activities at CDMO or technical service center externally.
- Prepare internal the standard operating procedure (SOP), and join in reviewing, evaluating the external partner's SOPs.
- Join in the formulation discussion group internally.
- Other related duties as assigned to meet company objectives.
- Support the process for data collection for PQRs.
Skills and Requirements:
- M.S. with above 8 years relevant work experience in Formulation Research and Development, scale-up, and drug product development etc.
- Comprehensive knowledge in preformulation, formulation design, and screening, etc.is preferred.
- Adequate knowledge and understanding of different enabling technology of formulation development.
- Adequate knowledge and experience of different Formulations like Immediate Release, Modified Release, Delayed Release, Sustained Release, Parenteral formulation, etc.,
- Knowledge of ICH, GMP, and local regulations, the working experience in GMP compliance is a plus.
- Sound technical writing experience.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.