Analytical researcher manager
Opportunity to lead more than 10 people from different backgrounds and countries
Strong RD team
About Our Client
Our client is a global pharmaceutical company that has strong resources in regional. They're expanding quickly and would need someone with solid analytical research experience in pharma.
- Review, revise and sign the release and stability test reports of finished products for Industrial Technology Development Program (ITDP) and non-ITDP. Plan for detailed investigation analysis to support Out of specification analytical data and to report and close deviation, if needed
- Planning for timely analytical method development for the analytical methods of finished products by ICH guidelines and Pharmacopoeia (USP, EP ...) and based on vendor's DMF.
- Conduct team member to write the analytical method validation protocol. Conduct to implement the analytical method validation experiment, follow up the progress of validation and review, revise and sign the analytical validation report. Assist group in trouble shooting and work scheduling.
- Review and ensure the specifications and establish the specifications and test methods of finished products.
- Search and read the professional literature, ICH guideline and Pharmacopoeia (USP, EP ...) in order to overcome the analysis problem and implement personnel training. Assist in recruitment and selection of new joiners, as needed.
- Discuss and evaluate department staff performance on annual basis
- Participate and report on weekly status meeting of ITDP and non-ITDP project.
- Plan for analytical testing for QbD batches and comparison dissolution testing of reference and test drug formulation
- Hold the department meeting and training
- Assist BD in evaluating material suppliers, CoA, MoA and contracts
- Inspection preparation meeting; QA review meeting and other matters assigned by the superior
The Successful Applicant
- A minimum of 5 years practical experience, 1 years of domestic and international cGMP pharmaceutical factory or management and technology in above area
- Be familiar with knowledge of domestic and international relevant regulations
- Demonstrate hands-on experience of analytical chemistry and instrumental analysis
- Demonstrate basic knowledge of pharmacy
- Domestic and international cGMP pharmaceutical or a related field of practical experience in management and technology
- Leadership: Proven ability to set standards, hold others accountable, build organizational capability and set strategy to deliver business objectives
What's on Offer
Our client offers good career progression and regional opportunities.