PD Director

A leading biopharma organisation is advertising a vacancy for a PD Director based in their office in Suzhou. The organisation develops cutting-edge immunotherapies that fight cancer, working on a pipeline of over 10 innovative molecules, including two IND filling ready assets targeting novel pathways in cancer immunotherapies. This vacancy is an exciting opportunity to work with a dynamic and innovative establishment.

Job Responsibilities:

• Lead a team of Scientists and Engineers to develop processes that meets the company's clinical manufacturing needs. The processes must be efficient, robust, and scalable for commercial manufacturing in the future.
• Lead and ensure successful process tech transfer (both internal and external) from PD to Manufacturing and method transfer from PD to QC (Conduct new production introduction assessment and gap analysis.
• Routinely monitor the manufacturing process performance against PD's process design, Review tech transfer protocol, MBR, PFD, manufacturing related documentation, etc.
• Functions within Process Development include: Cell Line Development, Cell Culture, Purification, Formulation, Analytical Sciences, and Tech Transfer.
• Coordinate the work between the Process Development group and other functional groups to meet the project objectives and timelines.
• Oversee and troubleshoot the process scale-up and technology transfer between the process development team and manufacturing team.
• Lead PPQ/PV (process performance qualification or process validation).
• Lead PC (process characterization).
• Lead or participate in key investigations of deviations. (Investigate, identify root cause, and identify CAPA).
• Coach the team and staff.
• Coordinate and lead PD related activities for outsourced projects with CDMO, CRO and other vendors.
• Support regulatory submission (INDs and BLAs).
• Other tasks assigned by management.

Skills and Requirements:

• MS in biochemistry, biophysics, chemistry, chemical engineering, molecular biology or other related fields with 10/14+ years of process development experience, or PhD with in the above mentioned field with 6/10+ years of process development experience.
• 3/6+ years' management experience ?experience management technical personnel).
• Experience in CHO cell culture (e.g. clone selection, media screening, FedBatch/Perfusion cell culture) and purification (e.g. chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal).
• Experience in process characterization.
• Experience in working with cross-functional teams.
• Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
• Experience in CMC and regulatory submission, including INDs and BLAs, to NMPA(CFDA)/FDA/EMA.
• Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
• Experience with statistical design of experiments (e.g., JMP), advanced data analysis, computation (e.g., modeling, optimization), and/or programming (e.g., Matlab) is preferred.
• 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.

To Apply:

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 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.

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