Senior Scientist- Quality Control Job at BioPhase, San Diego, CA

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  • BioPhase
  • San Diego, CA

Job Description

Sr. Scientist-ANALYTICAL DEVELOPMENT & QUALITY CONTROL

Seeking an experienced analytical chemist to join our QC & Analytical Development group at the Sr. Scientist level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a strong work ethic, have good communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

RESPONSIBILITIES:

  • Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples
  • Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology
  • Author scientific reports and portions of the CMC section of regulatory filings
  • Manage the analytical activities for therapeutic development projects
  • May develop and optimize analytical methods
  • Design and execute method validation and method transfer protocols
  • Manage outsourced analytical activities at external contract labs
  • Conduct analytical investigations
  • Present at internal and cross-functional scientific meetings

REQUIREMENTS:

  • MS with at least 10 years of industry experience in Analytical Chemistry or related discipline
  • Ph.D. with at least 7 years of industry experience in Analytical Chemistry or a related discipline
  • Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples
  • Good understanding of the drug development process
  • Practical knowledge of GMP requirements, with hands-on GMP experience preferred
  • Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
  • Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects
  • Ability to work productively and independently within a team or matrix environment
  • Good written and verbal communication skills

Job Tags

Contract work,

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