Formulation Expert

Highly Competitive
  1. Permanent
  2. Laboratory Technician
  3. China
Shanghai
Posting date: 30 May 2019
SC.TT.23605_1559216002

A global biopharmaceutical company is seeking to recruit a Formulation Expert to their office in Shanghai. The organisation is known for their work in discovering and developing molecularly targeted, oral small molecule drugs to treat liver diseases and cancers. This vacancy is an exciting opportunity to work with a company that combines expertise in disease biology and medicinal chemistry with a capital-efficient drug discovery model and extensive clinical development capabilities to advance its growing pipeline of drugs that are optimized against clinically-validated targets.

The Formulation Expert will be responsible for the whole development cycle of drug product, with a particular focus on later phase development (Commercial formulation and process development / Ph IIb & Ph III manufacturing / Technology transfer).

Job Responsibilities:

  • Mapping and executing the plan for drug product from FIH (First In Human) to NDA (New Drug Application) according to project timeline.
  • Working closely with chosen CMOs and providing timely feedback to management on possible impact to project timeline.
  • Supervising junior members of formulation group and providing guidance from technical and program perspective.
  • Authoring/reviewing DP related regulatory documents and interacting with Health Authorities (FDA / EMA / NMPA) in order to obtain regulatory approval.
  • Map the DP development plan from FIH to NDA to support the R&D portfolio
  • Actively identifying and addressing the bottleneck of drug product development and accelerating the overall progress whenever possible (stay out of the critical path).
  • Interacting with chosen CMOs on a daily basis and providing critical inputs on experiment design & objectives, data collection & format, interpretation of results, etc.
  • Overseeing commercial formulation and process development with internal and external resources, planning budget, and arranging FTE accordingly.
  • Working with CMO to successfully deliver the drug product for Ph II & Ph III in a compliant way, including the appropriate data sets and documentation.
  • Acting as the point of contact for drug products, providing input/feedback to management team on project updates, and alerting management on possible delays/changes in timeline whenever necessary.
  • Working with CMO to write and review the DP section for regulatory submissions.
  • Communicating with FDA/EMA/NMPA on any questions/issues related to drug product.

Skills and Requirements:

  • D. in formulation/pharmaceutics from an oversea university or significant oversea experience, with 5-8 year working experience in solid oral formulation R&D.
  • Prior experience in formulation and process development intended for commercial launch required
  • Prior experience in technology transfer and/or manufacturing setting highly preferred
  • Working knowledge in pre-formulation/salt & polymorph/novel formulation.
  • 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 Tom Tan at +86 21 51694101 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.

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