Team Lead, Quality Control (In-Process Controls & Validations)

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to 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 involved with disease. The depth and versatility of our RNAi technologies enable 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 collaborating to bring new therapies to patients in need.

The Position

This position is within the Quality Control structure, under the Quality Assurance Organization. The Team Leader, IPCs & Validations will manage chemists and support the analytical testing of pharmaceutical in-process manufacturing samples and validation activities (analytical methods and computer systems) for drug substances and drug products, while carrying out supervisory functions. They will work cross-functionally to resolve issues and may hold leadership roles for project support personnel.

The Team Leader IPCs & Validations will manage and support testing requirements. The candidate should be proficient in analytical techniques and capable of making independent scientific decisions. Responsibilities include drafting and maintaining study documents (testing directives, methods, reports), managing deadlines, and mentoring chemists new to the industry. This role reports to QC Laboratory Senior Management.

Responsibilities

• Management
  • Provide leadership and guidance to QC chemists, supporting their professional growth.
  • Set performance expectations, give feedback, and conduct evaluations.
  • Foster a collaborative, inclusive work environment encouraging teamwork, creativity, and innovation.
  • Participate in leadership meetings across departments.
• Scientific/Laboratory
  • Ensure compliance with cGMP and ICH guidelines.
  • Work independently to meet project timelines with minimal supervision.
  • Collaborate on procedural method transfers and participate in method validation protocols.
  • Proficient with analytical instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin readers, Raman spectroscopy).
  • Train staff on SOPs and instrumentation.
  • Serve as a subject matter expert on instrumentation and workflow management.
  • Coordinate with QA, Analytical Development, and Manufacturing for project execution.
  • Mentor entry and mid-level chemists.
  • Track and interpret data related to product stability.
  • Lead scientific discussions and troubleshoot analytical issues.
  • Maintain accurate notebooks and draft technical documents (OOS investigations, deviations, CAPAs).
  • Communicate testing issues effectively.
  • Perform calibration, maintenance, and troubleshooting of analytical equipment.
  • Make scientific decisions and serve as backup to senior management.
• Other Skills
  • Effective communication across organizational levels.
  • Basic computer skills and knowledge of MS Office and chromatography data software.
  • Ability to solve practical problems, interpret instructions, perform mathematical calculations, and analyze data.
  • Read and interpret SOPs, test methods, and technical documents.

Requirements

• Master's in Chemistry (or related field) with 5+ years relevant experience, or Bachelor's with 7+ years.
• Knowledge of cGMP and ICH laboratory operations.
• Experience with analytical instrumentation, test methodology/validation, data systems, and cGMP policies.

Salary range in Wisconsin: $85,000—$100,000 USD. Arrowhead offers competitive salaries and benefits. Applicants must have authorization to work in the US.

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