Senior Manager, Quality Control
Arrowhead Pharmaceuticals
4 hours ago
On-site
Verona, WI
Operations
Senior Manager, Quality Control
Responsibilities
- Provide daily oversight of QC testing activities for release, stability, in-process, environmental monitoring, raw material testing, microbial testing, and characterization testing.
- Manage sample scheduling, resource planning, and prioritization.
- Lead, coach, and develop QC analysts and supervisors; drive accountability via goal setting, feedback, and performance management.
- Support scaling/maturity of the QC organization and succession planning.
- Oversee execution and troubleshooting of analytical methods.
- Ensure analysts are trained, qualified, and operate with consistency and accuracy.
- Lead, author, and drive timely closure of laboratory investigations (atypical results, OOS, OOT, analytical deviations) with scientific rigor and data integrity.
- Troubleshoot complex test failures; partner with SMEs/analytical development on root cause and corrective actions.
- Perform and interpret data trending and statistical analysis (e.g., control charts/control limits/trend reports).
- Partner with QA on audit readiness/inspections and compliance improvements.
- Lead QC activities for lab expansion (equipment installation, qualification IQ/OQ/PQ, layout planning, workflow optimization).
- Support continuous improvement and readiness for system upgrades/enhancements.
- Serve as QC primary interface with Manufacturing, QA, Supply Chain, Validation/CSV, Analytical Development, and Program Leadership.
- Implement/track QC performance metrics and KPIs (turnaround times, deviations, testing cycle times, equipment uptime, trend analysis).
- Support readiness for commercial manufacturing and increasing analytical complexity.
Requirements
- B.S. or M.S. in chemistry or related field required.
- B.S. with 7+ years relevant experience; or B.S. with 10+ years relevant experience in GMP QC laboratory, including 7+ years in a leadership role.
- Demonstrated expertise in analytical instrumentation theory and practice.
- Strong knowledge of analytical methods (HPLC/UPLC, LC-MS, GC, UV, and other technologies).
- Pharmaceutical experience required; oligonucleotide testing experience strongly preferred.
- Preferred: experience with drug substance, drug product, and in-process validation/testing.
- Preferred: compendial methods (pH, osmolality, appearance, UV, endotoxin, bioburden, environmental monitoring).
- Strong understanding of data integrity, GxP, and regulatory expectations.
Benefits/Compensation & Application Instructions
- Wisconsin pay range: $145,000 USD - $165,000 USD.
- Competitive salaries and an excellent benefit package.
- All applicants must have authorization to work in the US.
Responsibilities
- Provide daily oversight of QC testing activities for release, stability, in-process, environmental monitoring, raw material testing, microbial testing, and characterization testing.
- Manage sample scheduling, resource planning, and prioritization.
- Lead, coach, and develop QC analysts and supervisors; drive accountability via goal setting, feedback, and performance management.
- Support scaling/maturity of the QC organization and succession planning.
- Oversee execution and troubleshooting of analytical methods.
- Ensure analysts are trained, qualified, and operate with consistency and accuracy.
- Lead, author, and drive timely closure of laboratory investigations (atypical results, OOS, OOT, analytical deviations) with scientific rigor and data integrity.
- Troubleshoot complex test failures; partner with SMEs/analytical development on root cause and corrective actions.
- Perform and interpret data trending and statistical analysis (e.g., control charts/control limits/trend reports).
- Partner with QA on audit readiness/inspections and compliance improvements.
- Lead QC activities for lab expansion (equipment installation, qualification IQ/OQ/PQ, layout planning, workflow optimization).
- Support continuous improvement and readiness for system upgrades/enhancements.
- Serve as QC primary interface with Manufacturing, QA, Supply Chain, Validation/CSV, Analytical Development, and Program Leadership.
- Implement/track QC performance metrics and KPIs (turnaround times, deviations, testing cycle times, equipment uptime, trend analysis).
- Support readiness for commercial manufacturing and increasing analytical complexity.
Requirements
- B.S. or M.S. in chemistry or related field required.
- B.S. with 7+ years relevant experience; or B.S. with 10+ years relevant experience in GMP QC laboratory, including 7+ years in a leadership role.
- Demonstrated expertise in analytical instrumentation theory and practice.
- Strong knowledge of analytical methods (HPLC/UPLC, LC-MS, GC, UV, and other technologies).
- Pharmaceutical experience required; oligonucleotide testing experience strongly preferred.
- Preferred: experience with drug substance, drug product, and in-process validation/testing.
- Preferred: compendial methods (pH, osmolality, appearance, UV, endotoxin, bioburden, environmental monitoring).
- Strong understanding of data integrity, GxP, and regulatory expectations.
Benefits/Compensation & Application Instructions
- Wisconsin pay range: $145,000 USD - $165,000 USD.
- Competitive salaries and an excellent benefit package.
- All applicants must have authorization to work in the US.