What are the responsibilities and job description for the Senior Analytical Scientist position at AL Solutions?
About the Job
A growing pharmaceutical Contract Development & Manufacturing Organization (CDMO) in Dallas, Texas is seeking an Analytical Development Scientist to support its expanding pipeline of sterile injectable drug products. This is a hands-on role within the R&D laboratory, ideal for someone with a strong analytical background and an expertise for method development in a GMP-regulated environment.
About the Role
As an Analytical Development Scientist, you will be responsible for developing, validating, and transferring analytical methods to support formulation, process development, and regulatory submissions. The position requires in-depth experience with HPLC/UPLC, mass spectrometry, and dissolution testing. You’ll work directly with internal teams and external partners to ensure successful execution of analytical activities across multiple development programs.
Key Responsibilities
- Develop, validate, and transfer analytical methods for raw materials, in-process materials, and finished drug products
- Perform hands-on analytical testing using HPLC/UPLC, MS, GC, and dissolution techniques
- Troubleshoot and optimize methods to ensure reproducibility and compliance with regulatory expectations
- Analyse and interpret data, author technical reports, protocols, and method validation documents
- Collaborate with cross-functional teams including Quality, Manufacturing, and Regulatory
Your Profile
- M.S. in Chemistry, Analytical Chemistry, or a related field, with at least 2 years of relevant experience, or a B.S. with 5 years of hands-on industry experience
- Strong technical expertise in HPLC/UPLC, GC, MS, and dissolution testing
- Familiar with physicochemical characterization techniques, including TGA, DSC, and particle size analysis
- Deep understanding of FDA and ICH guidelines, as well as compendial methods (USP/NF, EP)
What’s in It for You
- Join a growing CDMO that's making a real impact in the injectable drug product space
- Get hands-on with a broad range of projects and cutting-edge technologies in a team-oriented R&D environment
- Strong compensation and benefits, with real opportunities to grow your career
