Senior Analytical Chemist

6 days ago

Springfield, Illinois, United States curiate Full time
About the Role

We are seeking a highly skilled Analytical Chemist II or III to join our team at Curia, a global contract research and manufacturing services company. As a key member of our Quality Control and Assurance team, you will be responsible for developing and implementing analytical methods for new and existing products and processes.

Key Responsibilities
  • Develop and validate analytical methods for new and existing products and processes.
  • Transfer analytical methods from/to customers/vendors/other Curia sites as needed.
  • Validate analytical methods as required, including preparation of validation protocols, conducting validation experiments and preparation of validation reports.
  • Execute reference standard qualifications and prepare reference standard reports.
  • Train other analytical chemists or QC personnel as required on analytical methods and procedures.
  • Provide analytical support for QC projects. Work with multidisciplinary product and technology teams.
  • Perform appropriate testing and data evaluation for the development and justification of specifications.
  • Coordinate instrument qualification, maintenance and repair activities for laboratory equipment.
  • Operate in compliance with current Good Manufacturing Practices, Good Laboratory Practices and applicable ICH and FDA requirements.
  • Maintain spare parts for instrumentation.
  • Assist in the evaluation and cost estimates for new projects, if required.
  • Document and record work observation and results according to written SOP's.
  • Implement analytical methods to elucidate the types and quantities of impurities present in reaction mixtures, process streams, waste streams, intermediates and finished products.
  • Work with Technical Services staff to develop impurity profiles for Active Pharmaceutical Ingredients and regulated intermediates.
  • Ensure that work in the analytical development laboratories is carried out safely and in accordance with the site chemical hygiene plan, including wearing applicable personal protective equipment (PPE), including but not limited to: Lab coats, gloves, safety glasses, coveralls, and full-face respirator or PAPR device.
  • Conduct work in accordance with any regulatory requirements that may apply.
  • Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations, company policies and procedures, regulations and commit to continuously improve safety and environmental performance.
  • Other duties as assigned.
  • Keep up to date with relevant developments in chemistry and laboratory practices and bring them to the attention of the laboratory management.
Requirements
  • A minimum of a BS degree in a scientific field.
  • Analytical Chemist II (3-5 years of relevant experience)
  • Analytical Chemist III (5-8 years of relevant experience)
  • Must have a practical working knowledge of the operation of and maintenance of common analytical laboratory instrumentation such as GC, HPLC, IR, NMR, LC/MS and GC/MS and be willing to develop expertise in statistical design of experiments, Process Analytical technology, QbD, and or high through-put analyses.
  • Demonstrate technical competency and the ability to learn new processes, technical subject matter and the ability to apply broad technical knowledge to solve complex problems.
  • Demonstrate problem solving and analytical, report writing, computer literacy, verbal communication, presentation and planning skills and abilities.
Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to work in a chemical research laboratory environment and/or an office environment. Additionally, the employee may be required to enter the production area of a typical manufacturing facility, which has moving mechanical parts, and may have fumes or airborne particles, extreme heat, wet and /or humid conditions, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the environment is usually moderate. Personal protective equipment is available to mitigate any hazards that may be encountered as part of the job requirements.

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