QC Scientist II - Analytical Validation & Leadership

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Scientist II in Quality Control to support analytical method validation, transfer, and testing across API and drug product samples.

The role requires leadership in technical discussions and mentorship of junior staff in a cGMP environment. The successful candidate will prepare validation reports and SOPs, optimize methods, and track data trends to ensure accuracy and compliance.

Qualifications

• M.S. in Chemistry (or related field) with at least 5+ years of relevant laboratory experience, or B.S in Chemistry (or related field) with at least 8 years of laboratory experience.
• Experience and working knowledge of various analytical techniques, such as LCMS, HPLC/UHPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc.
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices
• Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules
• Knowledgeable of cGMP, ICH, CDER requirements
• Understanding of basic theories and principles of synthetic organic chemistry
• Strong attention to detail.
• Can perform tasks assigned with minimal supervision
• Works well with others and in a team environment
• Can be flexible with changing priorities

Responsibilities

• Know and adhere to Arrowhead Core Values, cGMP policies and procedures and relevant SOPs
• Work independently and with Analytical Development and manufacturing team to lead project timelines and deliverables.
• Owns and leads scientific technical discussions and brainstorming sessions with internal and external stakeholders.
• Guide junior scientists with technical guidance and training
• Serve as Analytical Project Coordinator or coordinate for on-going or new Analytical Validation and technical transfer projects, take ownership of analytical requirements needed, and provide accurate analytical results
• Prepare Analytical Validation technical reports, presentations, SOPs, and policies and procedures
• Support analytical methods optimization and improvement of existing ones, to support all stages of API and drug product.
• Ability to track/trend data and interpret degrative changes to the product on
• Demonstrate proficiency with various related analytical techniques, such as LCMS, HPLC/UPHPLC, GC, FTIR, UV/Vis, KF.
• Design and execute non-routine experiments.
• Analyze data/results and interpret outcome of experiments and propose appropriate follow-up
• Write project documentation (i.e. Analytical test methods, developmental reports and protocols)
• Assist with drafting Out of Specification and Deviations with minimal supervision
• Perform testing of test samples in support of API and drug release.
• Performs technical data review on data acquired by other QC analysts as applicable
• Other duties as assigned

Skills

Analytical techniques

Mentoring

Data analysis

Scientific writing

Project coordination

Education

M.S. in Chemistry

B.S. in Chemistry

Tools

LCMS

HPLC

UHPLC

GC

FTIR

UV/Vis

KF

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a Scientist II in Quality Control to support analytical method validation, transfer, and testing across API and drug product samples.

The role requires leadership in technical discussions and mentorship of junior staff in a cGMP environment. The successful candidate will prepare validation reports and SOPs, optimize methods, and track data trends to ensure accuracy and compliance.