Job Description

🌟 We're Hiring: Analytical Development Documentation Specialist! 🌟

We are seeking a detail-oriented Analytical Development Documentation Specialist to manage and maintain comprehensive documentation for analytical methods and processes. The ideal candidate will have extensive experience in analytical development, regulatory compliance, and technical writing to support our scientific operations and ensure quality standards.

📍 Location: Bristol, United States
⏰ Work Mode: Flexible office & remote
💼 Role: Analytical Development Documentation Specialist

What You'll Do:

• Review laboratory notebooks from Analytical Development scientists for:

  • Completion and compliance with GDP

  • Accuracy and clarity of data

  • Suitability of analytical methods and data to support development goals

• Provide technical support for separation-based assays, including:

  • HPLC such as RPLC, AEX, CEX, HIC, etc.

  • GC

  • CE-SDS

• Review and provide feedback on analytical methods, ensuring compliance with internal standards  and GMP requirements.
• Assess and review qualification protocols and reports for analytical methods that are going to be transferred to quality control team for GMP manufacturing support and release testing.
• Support preparation and review of development reports.
• Review and assist in generation of Certificates of Testing (CoT) for development batch release and stability time points.
• Ensure data and documentation meet all regulatory and internal compliance standards.

What We're Looking For:

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 5+ years of industry experience in analytical development or quality control within a regulated (GMP) biopharmaceutical or pharmaceutical environment.
  
• Strong working knowledge of separation-based analytical techniques, particularly HPLC, GC, and CE-SDS.
• Demonstrated experience in reviewing laboratory notebooks, technical reports, and GMP documents.
  
• Familiarity with method development and qualification principles
  
• Proficiency in document management systems is a plus.
  

• Experience with stability testing and strong familiarity with ICH guidelines, including but not  limited to: ICH Q1A–Q1E (Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products)
• Solid understanding of regulatory expectations for early phase clinical development, including appropriate analytical data packages to support IND-enabling studies.
• Prior experience supporting IND filings is a plus.
• Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.

Ready to make an impact? 🚀 Apply now and let's grow together!

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