Senior Analytical R&D Scientist - Method Dev & Validation

Smart Media; Chantilly (VA); On-site; USD 80,000 - 95,000; Full time

Job summary

Smart Media in Chantilly, Virginia, is seeking an experienced analytical chemist to lead method development and validation activities for pharmaceutical products. You will be responsible for overseeing analytical techniques, preparing SOPs, and ensuring compliance with FDA regulations.

Qualified candidates must hold a Master’s degree in Analytical Chemistry or a PhD and have relevant experience. The role also requires hands-on expertise with various analytical techniques.

Qualifications

• Minimum 5 years of experience with small molecule solid oral dosage analytical development.
• In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory guidance.

Responsibilities

• Plan and execute method development, validation, and tech transfer for various components.
• Prepare and review SOPs, protocols, and reports for compliance with regulatory guidance.

Skills

Knowledge of API, excipient and finish product in generic pharmaceuticals

Hands-on experience with drug substance and drug product analytical techniques

Excellent verbal and written communication skills

Excellent problem-solving and interpersonal skills

Education

Master's degree in Analytical Chemistry or related field with 5+ years OR PhD with 3+ years

Tools

HPLC

GC

MS

Dissolution

Spectroscopy

Job description

Smart Media in Chantilly, Virginia, is seeking an experienced analytical chemist to lead method development and validation activities for pharmaceutical products. You will be responsible for overseeing analytical techniques, preparing SOPs, and ensuring compliance with FDA regulations.

Qualified candidates must hold a Master’s degree in Analytical Chemistry or a PhD and have relevant experience. The role also requires hands-on expertise with various analytical techniques.