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Analytical R&D Lead

Position Overview

We are seeking a highly motivated and experienced Analytical R&D Lead to join our R&D department. This is a unique opportunity to play a leading role in the development of innovative pharmaceutical products throughout the entire product lifecycle, from early research through scale-up, regulatory submissions and commercialization. The successful candidate will lead analytical development activities in the R&D, collaborate closely with multidisciplinary teams, and drive solutions to scientific and technical challenges that support studies for both commercial and pipeline products.

Key Responsibilities

  • Support physicochemical characterization of pharmaceutical products using a variety of analytical techniques.
  • Lead analytical method development and optimization, including the continuous improvement of existing analytical methods for raw materials, drug substances and drug products.
  • Design, execute, and document analytical method validation and technology transfer activities, including protocol and report writing, execution and data analysis.
  • Support laboratory investigations, root cause analyses and troubleshooting of analytical and product-related issues.
  • Contribute to the establishment, assessment, and maintenance of product Critical Quality Attributes (CQAs).
  • Oversee and provide scientific leadership for analytical methods developed by CROs and external laboratories.
  • Provide analytical support to R&D teams across multiple development programs.
  • Support QC and MS&T investigations, troubleshooting activities and continuous improvement initiatives.
  • Ensure compliance with GMP requirements and regulatory expectations.
  • Serve as a subject matter expert in analytical development and provide technical guidance across multidisciplinary teams.

 

Qualifications

  • M.Sc. degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline.
  • At least 5 years of hands-on experience in Analytical R&D within the pharmaceutical industry.
  • Proven experience in analytical method development, validation, troubleshooting and technology transfer.
  • Strong knowledge of GMP regulations and compliance requirements.
  • Familiarity with FDA, USP, EP, ICH, and other applicable regulatory guidelines.
  • Experience supporting both small molecules and complex molecules, including peptides.
  • Strong scientific problem-solving skills and analytical thinking.
  • Demonstrated ability to work independently while managing multiple priorities in a dynamic environment.
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills and the ability to work effectively as part of a multidisciplinary team.
  • Highly motivated, proactive, and capable of performing under pressure.

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