Team Lead, Quality Control at Arrowhead Pharmaceuticals

Verona, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Apr, 26

Salary

100000.0

Posted On

22 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Analytical Techniques, cGMP Requirements, ICH Guidelines, HPLC, GC, LC-MS, KF, FTIR, Endotoxin Plate Readers, Raman Spectroscopy, Method Validation, Data Interpretation, Training, Troubleshooting, Communication

Industry

Biotechnology Research

Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Assurance Organization. A Quality Control Team Leader will manage chemists and help to support the analytical testing of pharmaceutical raw materials, in process manufacturing samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products while carrying out a supervisory function. The Quality Control Team Leader will also manage and support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Team Leader will also be expected to be proficient in several analytical techniques and will be capable of making independent scientific decisions. The position also requires the ability to lead and mentor chemists who are new to the industry. This position reports to QC Laboratory Senior Management. Responsibilities Management Provide leadership and guidance to a team of QC chemists, ensuring their professional growth and development. Set clear performance expectations, provide regular feedback, and conduct performance evaluations. Foster a collaborative and inclusive work environment that encourages teamwork, creativity, and innovation. Attend and contribute to regular leadership meetings between cross-functional departments. Scientific/Laboratory Fully knowledgeable of cGMP requirements and ICH guidelines Frequently 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 protocols Proficient with various analytical instrumentation theory and practice Executes training requirements for assigned SOPs and participates in department specific training Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in analyst training on instrumentation as Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization Works closely with QA, Analytical Development and/or Manufacturing personnel for efficient project execution and timely/accurate deliverables Trains and mentors both entry chemists as well as mid-level chemists Ability to track/trend data and interpret degrative changes to the product on stability Leads and assists in scientific technical discussions and brainstorming sessions Identifies and troubleshoots analytical method issues with instrumentation, general chemistry, test methodology and sample product Communicates laboratory testing issues or challenges to senior laboratory management Maintains a clear, concise, and accurate notebook Drafts technical documents such as OOS/atypical investigations, deviations and CAPAs Possesses clear written and verbal communication skills Embraces cGMP and ICH requirements for all associated work Calibration, maintenance, and troubleshooting of analytical equipment in collaboration with metrology Routinely makes sound, scientific decisions and serves as a back-up to Senior Laboratory Management Requirements Master's in Chemistry (or related field) with 5+ years relevant laboratory experience Bachelor's in Chemistry (or related field) with 7+ years of relevant laboratory experience Fully knowledgeable of cGMP and ICH laboratory requirements and operations Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices Wisconsin pay range $85,000—$100,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Responsibilities

The Quality Control Team Leader will manage chemists and support analytical testing of pharmaceutical materials and drug products. They will also lead and mentor new chemists while ensuring compliance with cGMP and ICH guidelines.