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.
- 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)
- 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