Quality Control Stability Manager

Location:
SC

Position Id:
20819


My client is a mid-sized biopharmaceutical organization on the fast-track to great product success. They are seeking an Quality Control Stability Manager with pharmaceutical experience and management/mentoring expertise for their Southeast location. They have doubled in size over the last 3 years and are projecting more exponential growth and to go public in the coming year.

Requirements:

  • BS or MS in Chemistry or related field
  • Minimum of 7 to 10 years in the Analytical Chemistry in a GMP environment
  • Extensive experience with QC Validations, Method Transfer, Stability requirements, CFR 21 and ICH guidelines
  • Strong strategic, problem-solving, and management skills
  • Data-driven decision-making and interfacing with stakeholders
  • Experience in laboratory techniques, instrumentation and QC activities (HPLC-UV, GCMS, KF, & IC)

Responsibilities:

  • Provide guidance and strategic direction to for stability testing for drug products and substances
  • Oversee 5 to 10 direct reports including daily activities for direct and indirect subordinates
  • Support and ensure quality and integrity of stability testing, reporting, deviations, CAPA’s and other quality documentation are compliant
  • Assist writing and editing SOP’s, trouble-shooting, method validations and transfer of work
  • Promote continuous improvement and train accordingly
  • Report trending and tracking of lab efficiency utilizing software tools (Empower 2 or 3 preferred)

This is a great time to join this organization. If qualified and interested, please send your resume to schedule a brief conversation. This a great growth opportunity with a competitive salary.

Keywords: Chemistry, Validation, Stability, HPLC, GC, GMP, FDA, Quality, Quality Assurance, PAI preparation, audits, Quality Ops, CFR 21, ICH, pharmaceutical, manufacturing, QC, Quality Control, Mentor, Train, KF, LIMS, Empower 2, Empower 3

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