The Position

This position is within the Quality Control structure, under the Quality Organization. Scientist II, Quality Control, will support the 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. 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. This position 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 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 (active pharmaceutical ingredient) 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

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.
• Can perform tasks assigned with minimal supervision
• Works well with others and in a team environment
• Can be flexible with changing priorities