Job Description

Analytical R&D Scientist II

Summary:

An industry leading pharmaceutical manufacturing firm is seeking to add a bright new Analytical Scientist to their growing team. The Analytical R&D Scientist II is responsible for the development and establishment of new analytical methods using advanced analytical techniques that meet the expected FDA standard, independently or under the supervision of a Senior Scientist. The primary focus will be on the development of oral solids, liquids and semi solids for FDA applications. Analytical R&D Scientist - II should be able to work on the bench, manage projects while working with other scientists and collaborating with other departments.

Responsibilities:

• Analytical R&D Scientist-II will be responsible for developing and /or validating HPLC/GC and other analytical test methods, and optimizing existing test method independently or under the supervision of a Manager,
• Performs analytical testing on R&D batches and associated stability studies and generate stability analysis report.
• Analytical testing will include Assay, preservative content, LOD, water content, identification test, dissolution, disintegration, residual solvents, related substances etc.
• Provide mentorship, training and guidance to associate level staff and contribute to their development.
• Performs experiments and studies such as reverse engineering, compatibility studies, degradation studies independently or under the supervision of a Senior Scientist.
• Assist in writing protocols, reports and technical documents including but not limited to development, validation and study.
• Ensure compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
• Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines

Requirements:

Education and Experience:

• Bachelor’s Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences is required with minimum of 5+ years of experience in analytical method development and validation.
• Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences is required with minimum of 3+ years of experience in analytical method development and validation.
• Comprehensive knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and Compendial references (USP/Ph. Eur., etc.)
• Experience using laboratory instrument data acquisition software (Empower, Chemstation etc.).
• Experience using laboratory Management System (Labvantage etc.).
• Experience with Microsoft Office (Word, Excel, Power Point, etc.).

• Knowledge, Skills and Abilities:
• Proven verbal and written communications skills.
• Good subordinate and peer relationship skills.
• A strong demonstrated belief in continuous improvement.
• Good knowledge of cGMP, FDA and international regulatory requirements
• General personal computer skills - word processing, spreadsheet, graphics, and database.
• Proven concern with working in a safe and environmentally correct manner.

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