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Methodology Deputy Manager / Sec...

APEX Pharma
Cairo, Egypt
APEX Pharma logo

Methodology Deputy Manager / Section Head

Cairo, EgyptPosted 23 days ago
86Applicants for2 open positions
  • 63Viewed
  • 23In Consideration
  • 1Not Selected

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Job Description

We Are Hiring: Methodology Deputy Manager / Section Head

We are looking for a Methodology Deputy Manager / Section Head to join our team. The selected candidate will lead the development, validation, and troubleshooting of analytical methods to ensure accuracy, reproducibility, and compliance with pharmaceutical analysis. This role requires a deep understanding of analytical methodologies, regulatory requirements, and research and development processes to support research and development activities effectively.

Job Accountabilities:

  • Lead the development of analytical methods for new drug molecules suitable for routine R&D work.
  • Validate all developed methods of analysis to ensure accuracy and reproducibility.
  • Troubleshoot and resolve issues encountered in developed analytical methods.
  • Document and maintain the Method of Analysis (MOA).
  • Analyze formulation trials conducted in collaboration with the Formulation section.
  • Perform comparative in-vitro analysis for R&D trials.
  • Manage NODCAR files for required products.
  • Ensure compliance with integrated quality, environmental, health, and safety systems related to analytical tasks.
  • Lead the development and enhancement of new analytical methods.
  • Transform business objectives into actionable research plans and deliver results effectively.
  • Stay updated with scientific literature, publications, and advancements in analytical methodologies.
  • Recommend and oversee the acquisition of new laboratory equipment and instruments to meet operational needs.
  • Review analytical method validations to ensure accuracy and compliance with specifications.
  • Ensure all new product analysis aligns with product specifications and regulatory standards.
  • Develop and present surveys, guidelines, and procedures to collect and analyze required data.

Job Requirements

  • Bachelor’s degree in Pharmacy, Sciences (Master’s degree is a plus).
  • 10+ years of experience in methodology within a reputable pharmaceutical company.
  • Must have experience in solid, semi-solid dosage form development and analysis, "Sterile experience is a Plus".
  • Strong expertise in analytical techniques such as HPLC, GC, UV, IR, and dissolution testing.
  • Proficiency in method development, validation, and transfer in compliance with ICH guidelines.
  • Solid understanding of GMP, GLP, and regulatory requirements from global health authorities (FDA, EMA, WHO).
  • Experience with regulatory requirements and industry best practices.
  • Strong leadership, decision-making, and team management skills.
  • Excellent problem-solving, time management, and effective communication abilities.

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