Team Lead, QC (In-Process & Validations)

@ Arrowhead Pharmaceuticals

Overview

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company developing RNA interference therapies for intractable diseases. The company leverages a broad portfolio of RNA chemistries and efficient delivery methods to trigger gene silencing mechanisms, aiming to address conditions with a genetic basis.

The Position

The Team Lead, QC (In-Process & Validations) manages a team of chemists to support analytical testing of in-process manufacturing samples and validation activities for drug substances and products. This role involves leadership, method development, and cross-functional collaboration with QA, Analytical Development, and Manufacturing teams.

Responsibilities

• Management: Lead and develop QC chemists, set performance expectations, and foster a collaborative environment.
• Scientific/Laboratory: Ensure adherence to cGMP and ICH guidelines, perform analytical testing, and execute method validations.
• Training & Mentorship: Train both entry-level and mid-level chemists, and provide technical guidance on instrumentation.
• Documentation: Draft and maintain study documents such as SOPs, testing directives, and CAPAs.
• Collaboration: Work closely with cross-functional teams to resolve testing issues and maintain accurate records.

Other Skills and Abilities

Proficiency in using analytical instruments (HPLC, GC, LC-MS, etc.), familiarity with Windows-based software, and strong analytical and communication skills are required. The candidate must be adept at problem solving, interpreting technical documents, and performing complex calculations.

Requirements

• Master's in Chemistry (or related field) with 5+ years of laboratory experience, or Bachelor's with 7+ years experience.
• Deep understanding of cGMP and ICH regulations.
• Experience with analytical instrumentation, method validations, and data acquisition systems.
• Authorization to work in the US.

Key skills/competency

Team Leadership, cGMP, ICH, Analytical Testing, Method Validation, Instrumentation, Documentation, Cross-functional Collaboration, Mentorship, Problem Solving