Job Description

Position Summary:

The Analytical Chemist conducts analytical testing on raw materials, longitudinal and accelerated stability, in-process, finished bulk, and finished products. Responsibilities include designing and implementing new processes, validations, and instrumentation as required. Testing is performed in compliance with cGMP, supporting the Analytical Lab management in maintaining a high-quality laboratory environment.

Responsibilities

• Prepare samples for testing on raw materials, in-process, and finished products.
• Physical and chemical testing in accordance with standard procedures, utilizing wet-chemistry and instrumental techniques.
• Operation and maintenance of scientific instruments including but not limited to HPLC, GC-FID, GCMS, TOC, EDX, UV-vis, and FTIR.
• Perform daily/monthly instrument calibrations to ensure all instruments are working properly.
• Write, review, and execute validations of assay methods.
• Maintain accurate, up-to-date and concise laboratory notebooks and records.
• Work closely as a team to complete all required tasks in a timely manner.
• Monitor product quality to ensure compliance to standards and specifications.
• Understand and precisely follow Standard Operating Procedures, global methods, local methods and published standard or compendia methods i.e. USP, ISO, ASTM.
• Understand and apply basic laboratory safety instructions, reagent handling precautions, and disposal of chemical waste according to local environmental regulations.
• Communicate with other departments regarding production, stability, and other business goals.
• Participate in/lead OOS investigations and other issues encountered in the analytical lab.
• Troubleshoot and perform maintenance on instrumentation as needed.
• Work with Shimadzu instrumentation provider to gain more training and knowledge of instrumentation.
• Participate in the maintenance and calibration of instrumentation via third-party vendors.
• Maintain inventory of required equipment and consumables.
• Train new and existing personnel on current SOPs and analytical techniques.
• Mentor lab technicians and newer staff members.
• Write SOPs for new and/or improving processes.
• A technical resource for annual SOP review.

Requirements

Required Skills/Abilities

• Knowledge of laboratory equipment set-up and operation, common laboratory techniques and safe chemical handling
• Excellent written, verbal and interpersonal communication skills
• Strong analytical, critical thinking, and problem-solving skills
• Ability to prioritize multiple responsibilities and manage deadlines accordingly.
• Communicate effectively with colleagues and all levels of management
• Exceptional attention to detail and high level of accuracy & organization
• Ability to work independently with minimal supervision in a fast-paced environment
• Ability to adapt quickly to changing policies and procedures
• Able to lead, mentor, and teach other personnel.
• Proficient knowledge of computers and Microsoft Office.

Required Education and Experience

• Bachelor's degree in a scientific field OR equivalent experience.
• Knowledge and practical experience with common analytical laboratory instrumentation (HPLC, GC-FID, UV-sis, FTIR).

Preferred Education and Experience

• Higher degree (Master's, doctorate) in a scientific field
• 2+ years of experience in Quality laboratory and/or analytical laboratory
• Method development and validation experience.
• Mechanical knowledge of analytical instrumentation.
• Knowledge of organic chemistry and GMP

Salary Description

$60k/yr - $80k/yr

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