Senior Chemist; Quality Control

About the role

The Senior Chemist is responsible for performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Technical Support). This includes the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation) and environmental samples, as well as documenting results in accordance with SOPs.

Responsibilities

• Follow all laboratory SOPs, including laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc.
• Perform laboratory chemical analysis on raw materials, in-process materials, and/or finished product using ICP-OES/MS, UV-Vis, Fluorescence, GC, HPLC/UPLC, titration, and other wet chemistry techniques.
• Execute assay testing, content uniformity testing, impurities analysis, validation testing (method, cleaning, process), and process/interpret data at an advanced level with minimal to no errors.
• Maintain a clean and organized laboratory working environment.
• Dispose of used/expired/excess chemicals, solutions, and solvents in dedicated waste receptacles.
• Report well-written, accurate, and timely results.
• Review data, calculations, notebooks, and reports.
• Perform and assist in laboratory investigations.
• Perform and assist in Cleaning, Method, and Process validation testing and protocol/report review.
• Maintain and troubleshoot laboratory equipment at an advanced level.
• Suggest improvements to existing testing methods when possible.
• Mentor and train entry-level and mid-level personnel on techniques performed in the lab and assist with laboratory-related questions as needed.
• Assist with routine Metrology functions, including instrument cleaning, preventive maintenance, calibration, and verification activities.
• Monitor and assist with maintaining proper inventory levels of all laboratory supplies.
• Assist with sample receiving, chemical inventory, document filing, and housekeeping.
• Ensure compliance with all safety policies and regulations, maintaining a strong regard for the safety and health of all personnel.
• Other responsibilities as assigned by Management.

Requirements

• Bachelor’s degree in a science-related field.
• At least 8 years of work experience in a laboratory setting preferred.

Skills

• Proficient in laboratory chemistry and cGMPs.
• Proficient in Microsoft Word, Excel, graphs/charts, and databases.
• Advanced level experience in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, and wet chemistry testing.
• Advanced level experience with analytical laboratory software.
• Able to multitask and meet tight deadlines.
• Excellent organizational skills with attention to detail.
• Able to effectively present results.
• Able to independently perform testing on all methods and troubleshoot most method issues with little or no help.
• Able to independently troubleshoot complex instrument issues with little or no help.

Physical Demands

• Required to sit and stand for long periods of time.
• Frequently reaching with arms/hands up to 2 feet.
• Good hand-eye coordination.
• Occasionally required to walk and kneel.
• Must be able to lift and/or move up to 50 pounds.
• Must be able to use close vision, distance vision, peripheral vision, color vision, and the ability to adjust focus.
• Required to reach with arms and use hands and fingers to handle or feel objects, tools, and computer controls.
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, and climb stairs.

Work Environment

• Work environment in laboratory and production operations facilities includes close proximity to heavy machinery and pharmaceutical powders.
• Potential to move between production operations sites/areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle.
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers.

Personal Protective Equipment

• Gowning as required by GMPs and/or SOPs.

Pay

$90,000 - $100,000 per year