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Job Ref. ID:  50401 
Job Title: Senior Research Analyst 2 - Analytical Technology Transfer
Division: Research & Development
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Senior Research Analyst 2 - Analytical Technology Transfer
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: The Senior Research Analyst 2 - Analytical Technology Transfer is responsible for Analytical Tech Transfer, method validation and verification activities. Routine job responsibilities include the writing, reviewing and executing of method validation protocol and reports. The Specialist will coordinate and assist in investigative testing. The Senior Research Analyst 2 - Analytical Technology Transfer will demonstrate technical expertise in R&D and QC functions and will provide expert levels of technical troubleshooting to the QC Team. The Specialist will work in a detail-oriented, compliant manor in a fast-paced, environment, on multiple concurrent projects. The role is expected to adhere to tight deadlines with shifting priorities, and expected to perform review of generated data for conformance to approved quality standards and must report any nonconformance or deviations to management in a timely manner for immediate required action. The Senior Research Analyst 2 - Analytical Technology Transfer responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. The role will report to Analytical Technology Transfer Manager - R&D and efficiently conduct all duties and responsibilities assigned and or delegated by the R&D Manager.
Key responsibilities & Accountability: Responsible for preparation of in-house technical documentation that support TT projects (Analytical' Specs, STMs, Transfer protocols, etc.). Order laboratory reagents and accessories for the products testing and method validation. Interact and collaborate with cross-functional team that includes operations, R&D, Quality Control, Regulatory and Supply Chain. Responsible for analysis of RLD samples. Perform method validation for the tech transfer products whenever required. Liaising with the CRO for successful technology transfer. Analysis of Pilot batches upon successful technology transfer. Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
 Qualifications: 
   - Education Bachelor's degree in Chemistry, Biochemistry or Pharmacy. Master degree is a definite advantage.
   - Experience: Minimum 2-3 years of experience in Pharmaceutical Industry is required, with major expertise in chromatography and spectroscopy and quality review in Analytical sections. Strong experience in review of data and manuscript of protocols and reports for analytical methods. Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.
   - Training:
Key Competencies: Strong technical writing, verbal communication, and presentation skills. Having an analytical mind with ability to think diversely, resolve problems with outstanding planning skill to manager and expedite complexities of procedures and regulations. Ability to critically analyse data using statistical tools and to compile technical reports. Develop, write, and review protocols, and reports for the following batches: Product Characterization, Technology Transfer, Exhibit/Registration, and Validation. Use knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects. Ability to work under pressure, plan personal and team workload effectively and delegate.  
Technical Competencies: Ability to critically analyse data using statistical tools and to compile technical reports. Knowledge of common and specific software in use in analytical labs. Knowledge of method development, validation, and method transfer. Knowledge of analytical methods/technologies as HPLC, A. As, GC, CE, ELISA, and/or other techniques. Strong knowledge with SOP writing, GMP compliance and data integrity requirements (21 CFR Part 210/211, Part 11).  
 

 
 

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