Scientist II, Quality Control

About the role

This position is within the Quality Control structure, under the Quality Organization. The Scientist II, Quality Control, will support analytical method validation, method transfer, and testing of pharmaceutical raw materials, in-process manufacturing samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Scientist II is 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 co-workers and reports to QC Laboratory Management.

Responsibilities

• Know and adhere to Arrowhead Core Values, cGMP policies and procedures, and relevant SOPs.
• Work independently and with Analytical Development and manufacturing teams to lead project timelines and deliverables.
• Own and lead 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 ongoing or new Analytical Validation and technical transfer projects; take ownership of analytical requirements 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 (active pharmaceutical ingredient) and drug product.
• Track and trend data, interpret degradative changes to the product.
• Demonstrate proficiency with various related analytical techniques, such as LCMS, HPLC/UHPLC, GC, FTIR, UV/Vis, KF.
• Design and execute non-routine experiments.
• Analyze data/results, interpret outcomes of experiments, and propose appropriate follow-up.
• Write project documentation (e.g., 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.
• Perform technical data review on data acquired by other QC analysts as applicable.
• Other duties as assigned.

Requirements

• 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 related 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.
• Ability to perform tasks assigned with minimal supervision.
• Works well with others and in a team environment.
• Flexibility with changing priorities.

Pay

Wisconsin pay range: $105,000 USD - $120,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.