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R&D Analytical Method developmen...

Al Andalous Pharmaceutic...
6th of October, Giza

R&D Analytical Method development & Validation Section Head

6th of October, GizaPosted 1 month ago
42Applicants for1 open position
  • 21Viewed
  • 5In Consideration
  • 6Not Selected

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Job Description

The Analytical Method development & Validation Section Head will oversee all activities related to analytical method development, optimization, and validation. This role involves strategic leadership, ensuring compliance with EDA as well as global standards (ICH, FDA, EMA), and providing technical guidance on analytical methods for pharmaceutical products. The successful candidate will be responsible for managing a team of scientists and analysts, driving projects to meet quality, timelines, and regulatory expectations.

Key Responsibilities:

• Lead and oversee the development, validation, and transfer of analytical methods.

•  Ensure all methods are compliant with regulatory requirements and align with EDA, ICH, FDA, and EMA guidelines.

• Develop and implement strategies for method optimization, troubleshooting, and validation processes.

• Develop and issue analytical methods, establish method specifications and define acceptance criteria within the necessary thresholds, ensuring compliance with regulatory standards set by ICH, WHO, FDA and EMA.

•  Manage a team of analytical chemists, providing mentorship, training, and performance feedback.

•  Coordinate with cross-functional teams (Quality, R&D, Production) to support product development and regulatory submissions.

• Monitor and evaluate emerging trends in analytical science and adapt methods accordingly.

• Lead investigations related to method-related OOS/OOT results, deviations, and CAPA implementation

Job Requirements

  • Bachelor’s degree in Pharmacy or Science.
  • Experience required (12: 15 )years in related role and not less than 3 years in the same position .
  • Master’s degree in Analytical Chemistry, Pharmaceutical Sciences is preferred.
  • Strong expertise in chromatography (HPLC, UPLC, GC), mass spectrometry, and other modern analytical techniques.
  • In-depth knowledge of global regulatory guidelines (WHO, ICH, FDA, EMA) for analytical method validation.
  • Excellent problem-solving skills, with a detail-oriented approach to analytical
  • Pharmaceutical industry experience is a must .
  • 6th October resident and nearby are preferred 

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