Senior Analytical Chemist

3 weeks ago

Reston, Virginia, United States BioPhase Full time

About the Role

The Senior Analytical Chemist will serve as a key member of the QC Analytical team at BioPhase, supporting the release of raw materials and finished products, method qualifications, and stability studies. This senior role will execute chromatographic, spectroscopic, and wet chemistry testing, and will also be responsible for technical writing and laboratory improvement initiatives.

Key Responsibilities

  • Perform high-quality chemistry testing to support routine manufacturing activities, new product method development, and stability testing.
  • Participate in protocol design for qualification of new methods and authoring of new procedures.
  • Utilize technical expertise in LC/GC to troubleshoot new methods and improve existing procedures, including diagnosing and making minor repairs.
  • Ensure testing is performed in compliance with relevant regulations, in a GMP/GDP environment.
  • Assist in the performance of internal and external audits.
  • Assume the role of Subject Matter Expert (SME) and trainer for individual techniques/instrumentation, including chromatography.
  • Maintain the laboratory working areas in a clean and organized state.
  • Provide technical support to other departments within the organization.

Required Knowledge, Skills, and Abilities

  • Strong communication and interpersonal skills.
  • Knowledge of quality systems, FDA, and compendium requirements.
  • Experience executing method qualifications in a GMP environment.
  • Wide range of analytical chemistry experience, including chromatography, spectroscopy, and wet chemistry.
  • Demonstrated excellence in LC/GC analyses.
  • Competency with routine software programs, such as MS Word and MS Excel.
  • Ability to learn complex software programs, such as Labware LIMS and Empower 3.

Required Education and Experience

  • Bachelor's or Master's degree in Chemistry.
  • At least 8 years of experience in a Chemistry Laboratory.
  • 5+ years of experience in a GMP QC Laboratory.
  • 2+ years of leadership experience (preferred).
  • Experience in a customer-focused laboratory environment (preferred).

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