First-level areas：Equipment Design and Manufacturing
First-level areas：Medical device manufacturing
Source：Social Recruitment
Job description ：
We are looking for a director/senior director. The Director of Formula Science will be responsible for leading the antibody formula development team and serving as a subject matter expert for pharmaceutical products.
Responsibilities include.
(1) Develop drug product formulations and transfer technology to manufacturing processes, with a focus on designing, planning, executing, and delivering formulations and process development research to parents.
(2) Applying the QbD method to improve the drug’s developability, developability, and process, in order to achieve consistent product quality.
(3) Write CMC drug related chapters and provide data supported comments to regulatory reviewers to achieve accurate and timely IND registration submissions and BLA/MAA files.

Skills and requirements.
(1) Doctor of Life Sciences with over 8 years of experience in drug development.
(2) Having a strong scientific background and in-depth knowledge of injectable development (biopharmaceuticals), device drug combination products, technology transfer, and process control strategies.
(3) Ability to understand complex processes, identify knowledge gaps, and propose effective and efficient solutions to problems.
(4) The latest knowledge of ICH guidelines and FDA/EMA/NMPA guidelines is related to biopharmaceutical development, manufacturing, and drug product stability.
(5) The ability to work independently in a cross functional team environment; Ability to manage multiple priorities and operate effectively.
(6) Strong technical writing and oral communication skills.

Please send your CV or resume as an attachment to the following email address:
mailto: rbhr@hrcenter.co.uk
With the subject line formatted as: ‘Name + Position + Company Name + Location’.