Pharmaceutical Development Manager
Excellent company benefit and regional scope
Strong pipeline and excited business plan
About Our Client
Our client is a global pharmaceutical company that's focusing on generics R&D. The company is now looking for Product Development candidates to expand their RD team.
- Responsible for QbD based formulation development and design of experiments, planning and proposal, conducting and monitor development progress of R&D projects.
- Executing pre-formulation and compatibility studies, strategic formulation development, setting specifications, scale up transfers and validation in defined time frame for oral solid dosage forms such as Tablets, soft & hard capsules (Immediate and Modified Release) relevant to various regulatory guidelines such as US and EU , TW, JP,CN ,KR & ROW
- Responsible for drawing up product development strategy based on literature search including research papers and patents.
- Help project management team in making project plan and ensure timely completion of activities.
- Interface with other departments such as clinical, quality, engineering etc. with respect to project related and departmental activities
- Responsible for writing up product development reports and other reports as required during product development
- Assist with troubleshooting of the handling of existing product formulation, API change and/or territory expansion projects
- Responsible for estimation and hiring and controlling personnel, assessment and appraisal and carrying out educational training plans.
- Draw up, manage, periodical maintain, and calibrate SOPs for departmental instrumental equipment. Monitor public safety and health. Ensure operation is in compliance with SOP and cGMP regulations
- Well versed with handling of pharmaceutical manufacturing equipment of pilot and commercial scale.
- Implementing quality initiatives to ensure standardization, efficacy and compliance of operations.
- Timely response to the deficiencies, information requests and complete response letters received on the filed products from the regulatory agencies.
- Understanding and analyzing critical aspects of projects such as timelines, cost, raw material, personnel and contributing for the effective management of the same.
The Successful Applicant
Strong Product Development experience with leadership experience.
Fluent English is a must
Strong culture builder with abundant cross broader communication experience
What's on Offer
Our client offers opportunities in global with great deals of career progression