Senior Scientist – Analytical R&D

Location: Allentown, PA

Scientific Search, a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products, has an immediate need for a Sr. Scientist, Analytical R&D. This is a 6-month contract-to-hire or direct hire position with a dynamic organization.

Using advanced analytical technologies, the Senior Scientist will design, manage, and implement analytical development activities to support all stages of drug development. She/he represents the department in CMC teams and actively contributes to team strategies. Collaborates with cross-functional groups to meet drug development milestones. Demonstrates strong problem-solving skills. Develops, validates and transfers analytical methods for drug substance, drug product and excipients. Independently manages multiple projects and ensures timely delivery of all deliverables. Maintain high standard of documentation of work including GLP/GMP. Conduct relevant reverse engineering on competitive products. Assist in other activities within R&D environment as assigned by the Manager. Act as a mentor to Scientist-I and Scientist-II.

Responsibilities

• Independently design and implement analytical development activities to support all stages of drug development.
• Develop, validate, and transfer analytical methods for drug substance, drug product and excipients.
• Must have knowledge and skills for Operation and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Autotitrator, FT-IR Spectrophotometer, Polarimeter, Mass spectroscopy, Laser Diffraction Particle Size analyzer, etc.
• Troubleshoot and solve analytical problems to assure timely completion of projects and technical reports to meet CMC project timelines.
• Proactively identify potential analytical or project issues and mitigate or address appropriately.
• Prepare, review and approve analytical data, technical reports and analytical methods.
• Provide mentorship, training and guidance to associate level staff assigned on the projects and contribute to their development.
• Must have skills for writing protocols, reports and technical documents including but not limited to analytical method development and validation.
• Actively participate in multiple CMC sub-teams: contribute to team strategies; provide high quality data to guide understanding and decisions; collaborate with other functional areas to solve technical problems and meet project development milestones.
• Proactively develop and maintain state-of-the-art knowledge in current pharmaceutical and analytical sciences related to drug development.
  
  

Requirements

• Bachelor’s Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences is required with minimum of 7 years of experience in analytical method development and validation.
• Master’s degree (MS/MA) in chemistry or other relevant pharmaceutical sciences is required with a minimum of 5 years of experience in analytical method development and validation.
• Understands regulatory requirements related to pharmaceutical analytical method development and validation.
• Extensive 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.). 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.
  
  

For immediate consideration, send current resume to John Barry;

john@scientificsearch.com & reference Job #19031

Check out scientificsearch.com for all current openings

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