Team Leader, Raw Materials

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI seeks a Quality Control Team Leader to manage chemists and oversee analytical testing for drug substances and products.

You will supervise GLP/Toxicology and clinical material testing while applying cGMP and ICH guidelines. The role requires leading a team, mentoring junior staff, and coordinating with QA, Analytical Development, and Manufacturing to ensure timely and accurate results.

Qualifications

• MS in Chemistry (or related field) with 5+ years laboratory experience.
• BS in Chemistry (or related field) with 7+ years laboratory experience.
• Fully knowledgeable of cGMP and ICH lab requirements and operations.
• Proficient with analytical instrumentation, method validations/transfers, data systems, and cGMP practices.

Responsibilities

• Provide leadership to a team of QC chemists and support professional growth.
• Ensure conformance to cGMP and ICH guidelines across testing and documentation.
• Mentor chemists, supervise testing for GLP/Toxicology and clinical materials as applicable.
• Collaborate with QA, Analytical Development and Manufacturing for timely deliverables.

Skills

Leadership

cGMP knowledge

ICH guidelines

Team mentoring

Independent work

Education

MS in Chemistry

BS in Chemistry

Tools

HPLC

GC

LC-MS

KF

FTIR

Endotoxin plate readers

Raman spectroscopy

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 and raw materials 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 raw material release and stability studies as applicable. 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{{:}}

• M.S. in Chemistry (or related field) with 5+ years relevant laboratory experience
• B.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

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.