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Job Ref. ID:  50385 
Job Title: Team Leader – Analytical Technology Transfer
Division: Manufacturing Science & Technology (MS&T)
Work Location: UAE (RAK head office)
Job Type: Team Leader
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: The Team Leader – Analytical Technology Transfer is responsible for supervision and technical direction over a team of specialists including total delivery of the project deliverables and services on time, within performance budget and meeting quality expectations. The Team Leader – Analytical Technology Transfer responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provide guidance and set standards in producing quality documentation, and provide timely and effective response and follow-through in issue resolution during technology transfer activities. The Team Leader will report to Analytical Technology Transfer Manager-MS&T and efficiently conduct all duties and responsibilities assigned and or delegated by the MS&T Manager.
Key responsibilities & Accountability: • Responsible for Review of TT Dossiers and prepare inhouse technical documentation that support TT projects (Analytical’ Specs, STMs, Transfer protocols. Etc) • Interact and collaborate with cross-functional team that includes operations, Quality control, Regulatory and Supply Chain. • Order laboratory reagents and accessories for the products testing and method validation. • Ability to critically analyse data using statistical tools and to compile technical reports. • Knowledge of common and specific software in use in analytical labs • Responsible for analytical leadership of a commercial program(s) including method lifecycle management, method transfer, validation and remediation. • Provide Technical subject matter expert technical support to commercial testing, stability programs and manufacturing operations. • Complete statistical analysis of data. Develop/write product manufacturing instructions. Initiate and execute action items as required for OOS, Change controls, CAPA’s, FMEA’s. Support new process start-ups including equipment and process development. • Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements. • Develop, write and review protocols and reports for the following batches: Product Characterization, Tech Transfer, Exhibit/Registration, and Validation. • Use knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects
   - Education • Bachelor’s degree in in Chemistry, Biochemistry or Pharmacy. • Master degree is a definite advantage
   - Experience: • At least 6-8 years of experience in Pharmaceutical Industry is required, with major expertise in chromatography and spectroscopy and Quality review in Analytical sections. • Should have handled similar role for a better fitment of this role. • Proven experience in review of data and manuscript of protocols and reports for analytical methods. • Proven experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.
   - Training:
Key Competencies: • In terms of competency you are highly result oriented with strong sense of accountability & ownership. • Motivated and highly organized professional and should be able to juggle competing priorities, with high level of integrity and professionalism. • Must demonstrate strong aptitude with Excellent technical knowledge • Excellent communication, interpersonal, decision skills required • Must have a solution centric mind to understand issues and solve them within a stipulated time frame, ability to understand new issues quickly and make scientific decisions. • Having an analytical mind with ability to think diversely, with outstanding planning and technical skills. • You must have excellent understanding of Pharmaceutical Business with ability to multitask and easily adapt in a fast-paced environment. • Ability to work under pressure, plan personal workload effectively and delegate. • You are a team leader with a proactive and collaborative approach can take initiative and easily adapt with changing business need and environment. 
Technical Competencies: • Strong knowledge of analytical methods/technologies as HPLC, A. As, GC, CE, ELISA, and/or other techniques. • Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements. • Extensive knowledge of method development, validation, and method transfer. • Strong Knowledge with SOP writing, GMP compliance and data integrity requirements (21 CFR Part 210/211, Part 11). 


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