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PD Director

Employer
Proclinical Staffing
Location
Jiangsu, Suzhou Shi, China
Salary
Negotiable
Start date
14 Aug 2019
Closing date
28 Aug 2019

View more

Discipline
R & D , Scientific
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

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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Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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