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Arrowhead Pharmaceuticals · 6 hours ago

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

Verona, Wisconsin, United States

Full-time

Onsite

Mid, Senior Level

$85K/yr - $100K/yr

5+ years exp

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Team Lead, IPCs & Validations will manage a team of chemists and support the analytical testing of pharmaceutical in-process manufacturing samples and validation activities while ensuring compliance with quality standards.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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

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

Qualification

CGMP knowledgeICH guidelinesAnalytical instrumentationMethod validationChemistry degreeData interpretationTechnical writingTeam leadershipCommunication skillsProblem-solving

Required

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