Analytical Development Scientist I: Method Validation

Alora Pharmaceuticals, LLC.; Fort Worth (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Alora Pharmaceuticals, LLC. in Fort Worth, TX is seeking an analytical chemist to support development activities for successful design, filing, transfer and launch of 505(b)2, ANDA and OTC products.

The role requires an advanced degree with a chemistry background and 2–5 years of pharmaceutical laboratory experience, with hands-on HPLC and Empower 3, and a strong emphasis on GMP/GDP/GLP/OSHA compliance. On-site lab work and collaborative teamwork are expected.

Qualifications

• Advanced degree with Chemistry background, Masters preferred.
• 2-5 years experience in pharmaceutical laboratory.
• Operation of HPLC and Empower 3 Software.
• Compendial/Non-compendial testing of raw materials.
• Adhere to all laboratory requirements per SOPs and regulatory practices (GMPs, GDPs, GLPs, OSHA).
• Analytical techniques include HPLC, dissolution, UV/Vis, FTIR, GC, titration, etc.
• Effective communication skills and project management.

Responsibilities

• Perform release and stability testing for raw materials and drug products.
• Execute method transfers and method equivalency studies.
• Conduct method validation experiments per written protocols.
• Characterize physical and chemical properties of drug products and raw materials.
• Peer review notebooks, data, protocols, and reports.
• Comply with cGMP, DEA regulations and quality procedures.
• Perform other tasks as assigned.

Skills

Analytical chemistry knowledge

Data analysis

Written & verbal communication

Education

Master's degree in Chemistry

2-5 years pharmaceutical lab experience

Tools

HPLC

Empower 3 Software

Job description

Alora Pharmaceuticals, LLC. in Fort Worth, TX is seeking an analytical chemist to support development activities for successful design, filing, transfer and launch of 505(b)2, ANDA and OTC products.

The role requires an advanced degree with a chemistry background and 2–5 years of pharmaceutical laboratory experience, with hands-on HPLC and Empower 3, and a strong emphasis on GMP/GDP/GLP/OSHA compliance. On-site lab work and collaborative teamwork are expected.