Director, Quality Control at Arrowhead Pharmaceuticals

Verona, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

210000.0

Posted On

20 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, GMP Regulations, Analytical Techniques, Project Management, Technical Writing, Leadership, Budget Management, Compliance Programs, Document Control, Scientific Knowledge, Product Testing, Multidisciplinary Projects, Staff Development, Regulatory Inspections, cGMP Compliance, Technical Expertise

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 The purpose of this position within the Quality and Compliance department is to lead Quality Control (QC) Laboratory consisting of analytical, microbial, stability, reference standard quality control. This includes the establishment and optimization of processes, procedures, analytical methods, and ensuring our Quality Control (QC) align with business strategy and needs. Functions as the GMP laboratory testing technical consultant to QC staff, business operations per strategic business needs. Responsibilities Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to manage QC laboratory including setting of vision and strategy, develop and manage operating budgets, management of technical employees, project management, and unit operational management. Apply scientific and technological expertise to the validation and optimization of analytical techniques for the identification and characterization of molecules oligo- and polynucleotides and raw materials in cGMP compliant laboratories. Apply extensive advanced scientific knowledge to design and manage multi-disciplinary projects. Provide leadership in product testing and Quality System to support overall business operations. Responsible for site processes and procedures related to Quality Control laboratory to ensure product quality and compliance. Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas. Apply advanced technical writing skills to prepare project protocols and reports to support product registration and/or business needs. Technical Reports and Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ). Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external partner’s needs. Represent QC function during 3rd party, QP, and regulatory inspections at Verona, WI facility. Hiring and development of QC department staff at the Verona, WI Other duties consistent with the position as assigned from time to time. Requirements: Master's Degree 10 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research 5 years of experience Directing QC laboratory in cGMP facility. Extensive knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with development of applicable compliance programs. Knowledge of GLP/GCP regulations Understanding of document control requirements in a FDA regulated Competent knowledge of and ability to use Microsoft Word and Excel Ability for occasional business Strong people leadership skills. Solid understanding of financials and budgetary management experience. Knowledge and understanding of operation of product quality control lab, product quality control requirement and system. Shows broad understanding of the issues relevant to the technical/science and business Preferred: Doctorate degree Wisconsin pay range $180,000—$210,000 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

Lead the Quality Control Laboratory, ensuring alignment with business strategy and compliance with regulations. Oversee the establishment and optimization of processes, procedures, and analytical methods within the QC laboratory.