Quality Control Chemist - Temporary Contract

Working with internal functional partners and selected consultants, this individual is responsible for supporting commercial starting materials, intermediates, drug substances and drug products.

** This is a part-time, temporary position for approximately 24 hours per week for 6 months.

Specific Responsibilities

• Review GMP data for release and stability testing on DS/DP • Manage reference standards in support of commercial products (RSMs/IMs/DS/DP)
• Work closely with CMOs/CTLs (contract testing labs) to oversee on-going and up-coming commercial stability lots/batches
• Work closely with analytical development at CCX to provide guidance on OOS/OOT investigations and lab deviations at the CTLs
• Review and archive COAs, stability protocols/reports, new revisions of test methods on RSMs/IMs/DS/DP from CTLs
• Work collaboratively with analytical development to support life-cycle management on commercial products
• Perform stability trending based on available stability data on DS/DP
• Other duties when requested

Requirements

• Bachelor in Chemistry or Biochemistry
• 3-5 years of QC experience in Pharma/Biotech
• Solid understanding of ICH, regulatory guidance and GMP principles
• Prior experience in chromatographic (LC / GC) and spectroscopic (IR / UV) techniques
• Familiar with other routine testing instruments, such as KF, dissolution, etc.
• Hands-on experience in compendial testing
• Thorough understanding of data integrity and good documentation practices • Knowledge of method validation and transfer is a plus