Manager, Quality Control (2nd Shift)

Arrowhead Pharmaceuticals•Verona, WI

8h•$110,000 - $130,000•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position falls within the Quality Control structure, under the Quality Organization. The Quality Control Manager will manage a team of chemists and help to support the analytical testing of pharmaceutical raw materials, in process manufacturing samples, finished drug substances and drug product, and stability sample testing activities for new drug substances and drug products while carrying out a leadership function. The Quality Control Manager will manage, and support testing required for clinical and commercial programs in the GMP QC laboratories at Arrowhead Verona site. The Manager is expected to be proficient in several analytical techniques and will be capable of making independent scientific decisions. The position requires the ability to lead and mentor new chemists who are new to the industry. May require occasional extended hours based on operational needs. 2nd shift work hours are 1 pm – 11:30 pm, Monday - Thursday, and includes a 10% shift differential.

Requirements

B.S or M.S in chemistry or related field required.
M.S. with 5+ years of relevant experience, B.S. with 7+ years of relevant experience in GMP QC laboratory, with 5+ years in a leadership role.
Demonstrated expertise with analytical instrumentation theory and practice.
Demonstrate proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, UV-Vis spectroscopy, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in analyst training on instrumentation as
Pharmaceutical experience required; experience with oligonucleotide testing strongly preferred.
Demonstrated experience with pharmaceutical drug substance, drug product and in-process validation and testing preferred.
Demonstrated experience with compendial methods: pH, osmolality, appearance, UV, endotoxin, bioburden, environmental monitoring.
Strong understanding of data integrity, GxP, and regulatory expectations.
Language Skills: Ability to read, analyze and interpret SOPs, test methods, procedural guides and associated technical documents. Ability to write in a clear and concise manner. Ability to effectively present/communicate information and respond to questions from management, peers and colleagues.
Mathematical Skills: Must be able to perform complex mathematical calculations, compute ratios, rate, and percent. Must be able to draw and interpret graphs and charts.
Reasoning Skills: Must be able to solve practical problems. Must be able to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Communication Skills: Ability to interact and interface with department management across various disciplines
Other Skills and Abilities: Must be able to work with people at various levels of the organization. Must have basic knowledge of computers and PC's. Ability to use windows-based software including MS Office and chromatography data collection software.

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
Provides leadership and guidance to a team of QC chemists, ensuring their professional growth and development.
Trains and mentors QC chemists
Sets clear performance expectations, provides regular feedback, and conducts performance evaluations.
Fosters a collaborative and inclusive work environment that encourages teamwork, creativity, and innovation.
Attend and contribute to regular leadership meetings between cross-functional departments.
Fully knowledgeable of cGMP requirements and ICH guidelines
Works independently to meet project timelines and deliverables with minimal supervision to no supervision
Collaborates with Analytical Development on procedural method transfers and may participate in the execution of method validation
Maintains and continuously develops proficiency with various analytical instrumentation theory and practice.
Execute training requirements for assigned SOPs and participate in department specific training
Is a subject matter expert in technical aspects of both instrumentation and workflow management and
Identifies and troubleshoots analytical method issues with instrumentation, general chemistry, test methodology and sample
Communicates laboratory testing issues or challenges to senior laboratory
Lead, author, and drive timely closure of laboratory non-conformances, including atypical results, Out‑of‑Specification (OOS), Out‑of‑Trend (OOT), and deviations.
Possesses clear written and verbal communication skills
Calibration, maintenance, and troubleshooting of analytical equipment in collaboration with metrology.
Acts with a high degree of judgement to make sound, scientific decisions and serve as a back-up to Senior Laboratory