- Perform a leadership role in qualitative and quantitative chemical analyses/experiments for Analytical Development laboratory
- Lead the method validation/transfer/verification testing for Analytical Development laboratory
- Write and review method validation protocols, reports, SOPs and investigation reports
- Perform basic pre-formulation study for various dosage forms
- Providing technical and scientific leadership to other team members including providing assistance in study design and providing training/coaching to other scientists
- Track and review the project progress
- Identify and quantify all ingredients in a reference formulation to ensue cost effective formulation is achieved.
- Perform and evaluate study for pre- formulation of solids, solutions, suspensions, gels, ointments, creams, suppositories and inhalers dosage forms
- Transferring new analytical techniques from different clients
- Lead all routine analytical testing for In-process, release, stability and method validation/transfer/verification activity
- Experienced in the critical analysis of complex molecules.
- Take a lead role for method development utilizing established scientific technique and automated instrumentation (UPLC, HPLC, GC, Dissolution, Auto titrate, AA, MS etc.)
- Lead out of specification investigation testing and investigation reports
- Write technical papers and reports; prepare standard and specifications for processes, facilities, products or tests
- Support IND, NDA, ANDA filing documents
- Ensure good relations and communications with all members of the team; respond professionally and in a timely fashion to internal and external customers
- Ability to handle hazardous waste, and lead safety programs for the laboratory
- Thorough knowledge for various laboratory software usages
- Other duties as assigned
- Analytical skills and knowledge of scientific protocols and complex scientific principles necessary to perform complex experiments and research on chemicals and medicines
- Problem Solving - Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions
- Research Skills - In-depth knowledge and expertise in developing new analytical method.
- Ability to design and conduct a systematic, objective, and critical investigation
- Advanced computer skills; ability to develop conclusions based on information from multiple sources
- A Master's Degree in Chemistry, Pharmaceutical Science or a related Science field
- A PhD Degree in Chemistry, Pharmaceutical Science or a related Science field
- 8+ Years working in pharmaceutical environment
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