Manager, Quality Control (2nd Shift)
Arrowhead Pharmaceuticals
4 hours ago
On-site
Verona, WI
Operations
Position: Quality Control Manager (GMP QC Laboratories, Arrowhead Verona site)
Responsibilities
- Provide daily oversight of QC testing activities to ensure accurate, timely release and stability testing.
- Manage sample scheduling, resource planning, and prioritization to support program timelines and ensure operational continuity.
- Lead and guide a team of QC chemists; provide training, mentorship, performance expectations, feedback, and performance evaluations.
- Foster a collaborative, inclusive work environment.
- Attend and contribute to cross-functional leadership meetings.
- Ensure full knowledge and application of cGMP requirements and ICH guidelines.
- Work independently to meet project timelines and deliverables.
- Collaborate with Analytical Development on procedural method transfers; may participate in method validation.
- Maintain and continuously develop proficiency with analytical instrumentation theory and practice.
- Execute SOP training requirements and participate in department training.
- Troubleshoot analytical method issues (instrumentation, general chemistry, test methodology, sample).
- Lead/author and drive closure of laboratory non-conformances (atypical results, OOS, OOT, deviations) and communicate issues to senior laboratory.
- Lead calibration, maintenance, and troubleshooting of analytical equipment with metrology.
- Make sound scientific decisions; serve as backup to Senior Laboratory.
Requirements
- B.S. or M.S. in chemistry or related field (required).
- M.S. +5 years relevant experience, or B.S. +7 years relevant experience in GMP QC laboratory; +5 years in a leadership role.
- Demonstrated expertise in analytical instrumentation theory and practice.
- Proficiency with analytical instruments (e.g., HPLC, GC, LC-MS, KF, FTIR, UV-Vis, endotoxin plate readers, Raman) and ability to assist in analyst training.
- 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.
Preferred
- Ability to read/analyze SOPs and technical documents; write clearly; communicate effectively.
- Ability to perform complex calculations and interpret graphs/charts.
- Ability to solve practical problems and interpret instructions in written/oral/diagram/schedule form.
- Ability to interface with management; basic computer/PC knowledge; proficiency with MS Office and chromatography data systems.
Pay
- Wisconsin pay range: $110,000–$130,000 USD.
Application instructions
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities
- Provide daily oversight of QC testing activities to ensure accurate, timely release and stability testing.
- Manage sample scheduling, resource planning, and prioritization to support program timelines and ensure operational continuity.
- Lead and guide a team of QC chemists; provide training, mentorship, performance expectations, feedback, and performance evaluations.
- Foster a collaborative, inclusive work environment.
- Attend and contribute to cross-functional leadership meetings.
- Ensure full knowledge and application of cGMP requirements and ICH guidelines.
- Work independently to meet project timelines and deliverables.
- Collaborate with Analytical Development on procedural method transfers; may participate in method validation.
- Maintain and continuously develop proficiency with analytical instrumentation theory and practice.
- Execute SOP training requirements and participate in department training.
- Troubleshoot analytical method issues (instrumentation, general chemistry, test methodology, sample).
- Lead/author and drive closure of laboratory non-conformances (atypical results, OOS, OOT, deviations) and communicate issues to senior laboratory.
- Lead calibration, maintenance, and troubleshooting of analytical equipment with metrology.
- Make sound scientific decisions; serve as backup to Senior Laboratory.
Requirements
- B.S. or M.S. in chemistry or related field (required).
- M.S. +5 years relevant experience, or B.S. +7 years relevant experience in GMP QC laboratory; +5 years in a leadership role.
- Demonstrated expertise in analytical instrumentation theory and practice.
- Proficiency with analytical instruments (e.g., HPLC, GC, LC-MS, KF, FTIR, UV-Vis, endotoxin plate readers, Raman) and ability to assist in analyst training.
- 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.
Preferred
- Ability to read/analyze SOPs and technical documents; write clearly; communicate effectively.
- Ability to perform complex calculations and interpret graphs/charts.
- Ability to solve practical problems and interpret instructions in written/oral/diagram/schedule form.
- Ability to interface with management; basic computer/PC knowledge; proficiency with MS Office and chromatography data systems.
Pay
- Wisconsin pay range: $110,000–$130,000 USD.
Application instructions
- Candidates must have current, valid authorization to work in the country where this role is located.