Formulation Director - Smallmo

A company specializing in life sciences is looking for a Formulation Director.
Your New Company
This is a HK listed company with a high reputation in Shanghai. They provide an innovative and supportive working environment and actively encourage career development. Due to the company's growth and future expansion, they are looking for a Formulation Director.

Your New Role
• Supervise and support formulation development team to develop, optimize, scale-up, and manufacture CTM in support of IND, early and late stage clinical studies.
• Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials.
• Develop dissolution strategy to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage form.
• Work with CMOs or commercial plant to assist gap analysis, risk assessment, tech transfer, process DOE and optimization.
• Coordinate with external collaborators including international Pharmaceutical companies to co-develop formulations and to overlook the projects’ progress.
• Evaluate and manage CMOs to ensure timely delivery of CTMs with high quality.
• Draft and review regulatory filing documents of IND and NDA for NMPA, FDA, EMA and TGA, etc.
• Prepare and participate interactive technical meetings with external collaborators and official reviewers in CDE.
• Collaborate with other functional groups in pharmaceutical development, regulatory affairs, and clinical supply operation and contractors.

What you'll need to succeed
• Ph.D in pharmaceutical science or related fields.
• Over 10 years’ experience in formulation or drug product development. Overseas working experience in global pharmaceutical company is preferred.
• Familiar with pharmaceutical industry regulations such as ICH, NMPA and FDA guidance etc. IND and NDA experience for FDA or EMA is preferred.
• Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.
• Fluent English (oral and writing) communication skills.

What you'll get in return
· Stable development platform
· Positive working atmosphere
· Excellent working partner

What you need to do now
If you are interested in this position, please contact Emma Guo via email or phone +8618301987576 for more information.
If the job isn't suitable for you, but you're looking for a new position, please get in touch and we'll discuss your career in confidence.



Job Type
Life Sciences

Talk to a consultant

Talk to Emma Guo, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: +8618301987576