Senior Analytical Scientist: Method Development & Validation

Sovereign Pharmaceuticals; Fort Worth (TX); Vor Ort; USD 105.000 - 135.000; Vollzeit

Zusammenfassung

Sovereign Pharmaceuticals in Fort Worth, TX is seeking an experienced Analytical Development Scientist to support 505(b)2, ANDA, and OTC product programs. You will perform release and stability testing, develop and validate methods, and contribute to method transfers and validation efforts.

The role requires advanced chemistry training, 8–12 years in pharma labs, and proficiency with HPLC, Empower 3, and MasterControl QMS.

Qualifikationen

• Advanced degree with Chemistry background; Master’s preferred.
• 8–12 years of experience in a pharmaceutical laboratory.
• Operation of HPLC and proficiency with Empower 3 Software.
• Compendial/Non-compendial testing of raw materials.

Aufgaben

• Perform release and stability testing for raw materials and drug products.
• Develop and validate analytical methods on various quantitative instruments.
• Execute method transfers and method equivalency studies.
• Conduct method validation experiments as per written protocols.
• Author technical documents such as protocols and reports.
• Peer review laboratory notebooks, data, protocols, and reports.
• Train other analysts on new instrumentation and techniques.
• Utilize MasterControl QMS Software to train on, review, and approve official documents.

Kenntnisse

Analytical thinking

Project management

Communication skills

Organizational skills

Self-starter

Ausbildung

Master’s degree in Chemistry

Tools

HPLC

Empower 3 Software

GC

Mass Spectrometry

UV/Vis

Jobbeschreibung

Sovereign Pharmaceuticals in Fort Worth, TX is seeking an experienced Analytical Development Scientist to support 505(b)2, ANDA, and OTC product programs. You will perform release and stability testing, develop and validate methods, and contribute to method transfers and validation efforts.

The role requires advanced chemistry training, 8–12 years in pharma labs, and proficiency with HPLC, Empower 3, and MasterControl QMS.