Scientist-I – Analytical R&D

Scientist-I – Analytical R&D

Allentown, PA
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Scientific Search client, a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products, has an immediate need for a Scientist I, Analytical R&D. This is a full time direct hire position with a dynamic organization.

The Analytical R&D Scientist-I is responsible for supporting product development trial samples testing and method development/validation primarily stability-indicating analytical methods that are applicable to pharmaceutical products. This position requires in depth knowledge and hands-on experience in Analytical techniques involving liquids, semi-solids and solid dosage form products. Analytical R&D Scientist - I should be able to work on the bench, manage projects while working with other scientists and collaborating with other departments.

Responsibilities:

• Under the supervision of a Senior Scientist, Analytical R&D Scientist-I will be responsible for testing R&D samples, developing and /or validating HPLC/GC and other analytical test methods, and optimizing existing test methods.
• Perform 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.
• Operates general analytical instruments during routine testing including but not limited to HPLC, GC, KF /Automatic titrator, FT-IR, Polarimeter, UV/Vis spectrophotometer, melting point apparatus, dissolution and disintegration units and Malvern Particle size analyzer.
• Complies with all current Good Manufacturing Practices (cGMP) current Good Laboratory Practices (cGLP) and Environmental Health & Safety (EHS) requirements, laboratory Standard Operating Procedures (SOPs) and company policies and procedures.
• Compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
• Multi-task by working on several simultaneous projects. Perform other duties as assigned.

Requirements:

Education and Experience:

• Bachelor/Master’s Degree in Chemistry with minimum of 2-4 years of experience in a pharmaceutical analytical laboratory using HPLC, GC, UV, IR TLC, KF and other instrumental techniques.
• 1-2 years of experience in analytical method development and validation will be preferred.
• Understands regulatory requirements related to pharmaceutical product development.
• 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 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.