Sr. Lab Analyst1

Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility, making the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions. Key industries served include healthcare, personal & home care, mobility, infrastructure, and specialty paper & packaging. A Responsible Care® company, Aurorium follows the highest regulatory standards across all manufacturing facilities.

About the role

The Senior Analyst serves as the primary subject matter expert (SME) for high complexity analytical and wet chemistry in a CGMP environment. This role is responsible for the entire analytical lifecycle—from method development and validation to routine testing and equipment lifecycle management. Beyond technical execution, the Senior Analyst provides mentorship, training, and technical oversight to laboratory staff to ensure high-quality data in compliance with global regulatory standards.

Responsibilities

• Lead the setup, daily tuning, and routine operation of ICP-MS and other specialized analytical equipment such as AA, GC, HPLC, etc.
• Perform analytical and wet chemistry testing in accordance with approved methods and specifications.
• Design and develop robust analytical methods for trace elemental analysis using ICP-MS across various matrices.
• Author and execute validation protocols in accordance with ICH and USP guidelines.
• Establish appropriate digestion techniques (e.g., microwave-assisted, open-vessel) and optimize collision/reaction cell parameters (KED/CRI) to mitigate polyatomic interferences.
• Prioritize and coordinate daily QC laboratory activities with the Quality Unit including sample testing, data review, documentation, and timely batch release.
• Perform complex troubleshooting of instrument hardware and software.
• Review and approve analytical data batches for accuracy, ensuring full adherence to data integrity principles and CGMP.
• Oversee the preventive maintenance schedule and calibration programs for laboratory instrumentation to ensure zero downtime.
• Oversee the stability testing program and ensure compliance.
• Manage relationships with external service providers and coordinate equipment qualification activities (IQ/OQ/PQ) for new equipment installations.
• Maintain inventory of NIST standards and reagents for calibration.
• Develop and deliver technical training programs for Lab Analysts on elemental testing, equipment maintenance, and sample preparation techniques.
• Serve as the technical lead during internal and external audits (e.g., FDA, ISO, Customer Audits).
• Mentor staff on proper laboratory safety and hygiene and the "trace-metal mindset" required for ppb/ppt-level analysis.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and corrective and preventive actions (CAPAs).
• Collaborate effectively with cross-functional teams including Manufacturing, QA, Supply Chain, Warehouse, and EH&S.
• Comply with company Health, Safety, and Environmental policies, procedures, and arrangements.
• Report all Health, Safety, and Environmental accidents, incidents, and near misses promptly.
• Act in a safe and responsible manner at all times.
• Participate in continuous improvement activities and problem-solving.
• Take responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business.
• Assist in the training, mentoring, and assessment of other team members.
• Exercise autonomy and judgment subject to overall direction or guidance.

Requirements

• 5–8 years in an analytical laboratory environment, with a minimum of 3 years of hands-on expertise specifically in ICP-MS, HPLC, GC, AA, and wet chemistry testing.
• Deep understanding of cGMP and pharmacopeial requirements (USP, EP, JP) for elemental impurities.
• Familiarity with method development, validation, and stability testing activities.

Qualifications

• B.S./M.S. in Chemistry, Analytical Chemistry, or a related scientific field.
• Strong working knowledge of cGMP regulations and laboratory compliance.
• Demonstrated ability to operate independently or in a team environment.

Skills

• Strong communication and interpersonal skills, with the ability to work effectively across teams.
• Excellent attention to detail and strong problem-solving abilities.
• Ability to prioritize tasks and manage multiple responsibilities.
• Proficient in laboratory documentation, data review, and electronic systems (e.g., SAP, LIMS).
• Capable of making sound technical decisions and escalating issues appropriately.
• Embodies Aurorium’s core values: credible, outcome-oriented, driven, and empowered accountability.

Benefits

• Medical, dental, and vision insurance
• Life and disability insurance
• 401(k) retirement plan
• Flexible spending accounts and health savings accounts
• Paid time off and paid holidays