Senior Analytical Development Scientist

Sovpharm; Fort Worth (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Sovpharm is seeking an experienced analytical chemist to support development activities for 505(b)2, ANDA, and OTC products in a pharmaceutical lab environment.

The role involves release and stability testing, method development/validation, and method transfers using HPLC, dissolution, UV/Vis, FTIR, MS, GC, and other techniques. Strong communication, project management, and training skills are required. Extended hours may be needed.

Qualifications

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

Responsibilities

• Support analytical development activities for design, filing, transfer, and launch of products (505(b)2, ANDA, OTC)
• Perform release and stability testing for raw materials and drug products
• Develop and validate analytical methods on quantitative instruments
• Execute method transfers and method equivalency studies
• Conduct method validation experiments per protocols
• Author protocols and reports; train analysts on instrumentation
• Peer review notebooks, data, protocols, and reports
• Identify non-routine problems and propose solutions
• Ensure compliance with cGMP, DEA regulations, and quality procedures
• Recommends new technology to meet dept goals
• Utilize MasterControl QMS to train, review, and approve documents
• Work with toxic and caustic chemicals in lab environment

Skills

Analytical chemistry

HPLC

Dissolution

UV/Vis

FTIR

Mass spectrometry

GC

Titration/electrode chemistry

Empower 3 Software

MasterControl QMS

Education

Advanced degree in Chemistry

Master’s preferred

Tools

Empower 3 Software

MasterControl QMS

Job description

Sovpharm is seeking an experienced analytical chemist to support development activities for 505(b)2, ANDA, and OTC products in a pharmaceutical lab environment.

The role involves release and stability testing, method development/validation, and method transfers using HPLC, dissolution, UV/Vis, FTIR, MS, GC, and other techniques. Strong communication, project management, and training skills are required. Extended hours may be needed.