Research and Development Analytical Specialist

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QUALIFICATIONS AND JOB DESCRIPTION

Qualifications

• Background: University degree preferably in Chemistry, Pharmacy, and Chemistry Engineering. Master’s degree or PhD is preferred
• Completed military service for male candidates (only applicable to male candidates)
• English: B level (capable to express verbally; understand a conversation; reading and writing)
• Experience: minimum 2 years of Analytical Laboratory experience in R&D department
• Experienced user of analytical equipment (HPLC, Dissolution, GC, etc.)
• Knowledge of cGLPs and Data Integrity requirements
• Strong analytical and critical thinking. Capable to plan experiments, analyze results and draw conclusions and next steps.
• Good computer skills, good command of MS Office programs
• Prone to teamwork, strong communication and relationship management
• Capable to work under pressure, meet deadlines, and work on multiple projects simultaneously.
• Knowledge of pharmaceutical tools (like monographs, pharmacopeias, guidelines, etc.) that support analytical development and validation work.

Job Description

• Evaluate and implement new technologies required to maintain state-of-the-art analytical methods for development and marketed products.
• Plan and execute analytical method development, pre-validation and validation studies: from protocol to reporting.
• Plan and execute stability analyses: from protocol to reporting.
• Execute routine Analytical Research activities of drug products (formulation trials and process validation of GMP batches).
• Routinely assess testing monographs and proactively maintain compliance of all activities with current official regulations, pharmacopeias, and SOPs.
• Preparation and review of Specifications, Method of analysis procedures and Analytical development reports.
• Support analytical methods activities of marketed products (Deficiency letters, methods revamping, etc.).
• Technical assessment & Analysis of drug substances (API) for projects execution.
• Preparation of analytical technical documents for dossier / Technology transfer executions / Regulatory submissions of projects.
• Assisting and resolving technical queries raised during Technology transfer activities & regulatory submissions.
• Ensure right first time in all analysis and documentation.
• Procurement and management of analytical consumables and external services (outsourcing).
• Conduct analytical transfer activities (inter-department/intra-department).
• Support the company for growth and continuous improvement.
• Any other specific functional activities defined on case to case basis.