Analytical Laboratory Manager

3 weeks ago


Reston, Virginia, United States Astrix Full time
About the Role

Astrix is seeking a highly skilled Senior Quality Control Chemist to join our team as an Analytical Laboratory Manager. This is a key position that will oversee and conduct quality control testing, while preparing and maintaining stability records and summaries.

Key Responsibilities
  • Quality Control Oversight: Ensure the accuracy and reliability of quality control testing, including the preparation and maintenance of stability records and summaries.
  • Method Development and Transfer: Develop, train, and transfer analytical methods to and from quality control and contract manufacturers as needed.
  • Procedure Validation: Modify and validate analytical procedures to meet quality control requirements.
  • Experimental Design and Documentation: Design and develop experimental protocols, SOPs, and related documentation in line with cGMP/GLP standards.
  • Batch Release: Perform all quality control chemical tests required for batch release to ensure patient safety.
  • Special Projects: Participate in and lead special projects, providing input, feedback, and executing assigned tasks.
  • Instrumentation Maintenance: Maintain, operate, and adapt analytical instrumentation as needed.
  • Regulatory Compliance: Ensure a clean, safe work environment that complies with safety and pharmaceutical regulations.
  • Reporting and Communication: Report monthly on quality control supply orders for devices and reagents.
  • Industrial and R&D Activities: Contribute to industrial, R&D qualification, and validation activities, while supporting routine maintenance.
  • Root Cause Analysis: Lead laboratory investigations and root-cause analyses.
  • Reagent Preparation: Prepare chemical reagents for manufacturing and quality control processes.
Requirements
  • Experience: 5 years of GMP quality control laboratory experience, including leadership experience.
  • Education: Bachelor's degree in chemistry or biochemistry is required.
  • Skills: Proficiency with analytical techniques, including High-Performance Liquid Chromatography (HPLC), excellent oral and written communication, organizational, and problem-solving skills, with the ability to work under strict timelines.
  • Knowledge: Knowledge of current analytical methods for testing, release, and stability of sterile pharmaceutical products.
  • Teamwork: A team-oriented mindset, with the ability to work effectively with cross-functional teams.
  • Technical Skills: Proficiency in Microsoft Word and experience with Laboratory Information Management Systems (LIMS).

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