Analytical Development Scientist I

Avion PharmaceuticalsFort Worth, TX
Onsite

About The Position

Support Sovereign’s analytical development activities to achieve successful design, filing, transfer and launch of 505(b)2, ANDA and OTC products.

Requirements

  • Advanced degree with Chemistry background, Masters preferred
  • 2-5 years experience in pharmaceutical laboratory
  • Operation of HPLC and efficient with Empower 3 Software
  • Compendial/Non-compendial testing of raw materials
  • Adhere to all laboratory requirements in accordance with SOPs and regulatory practices such as GMPs, GDPs, GLPs, and OSHA regulations.
  • Understanding of Analytical Chemistry including but not limited to the following techniques and how to utilize them, as needed, for projects, both simple and complicated, as assigned: HPLC, Dissolution, UV/Vis, FTIR, Sample Preparation Techniques, GC, Titration/electrode chemistry, Others as appropriate
  • Effective communication skills, written and verbal
  • Demonstrate project management skills
  • Organizational and interpersonal skills
  • Authorized to work in the U.S.

Nice To Haves

  • Ability to innovate new ideas

Responsibilities

  • Perform release and stability testing for raw materials and drug products
  • Execute method transfers and method equivalency studies
  • Conduct method validation experiments as per written protocols
  • Performs characterization of physical and chemical characteristics of drug product and raw materials.
  • Peer review laboratory notebooks, data, protocols and reports
  • Understands applicable cGMP, DEA regulations and Quality Procedures
  • Performs other tasks as assigned.
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