Senior Analytical Chemist

We are seeking a Senior Analytical Chemist to support development of analytical methods for our pharmaceutical clients.   The successful candidate will be a hands-on person of high integrity who can succeed on our results oriented team.   Primary responsibilities of this position are:

  • Development of assay and purity methods for novel APIs, intermediates and starting materials. This includes the documentation of development activities and preparation/revision of test methods.
  • Validation of analytical methods using HPLC, HPLC/MS, GC, and GC/MS. This includes the preparation and execution of protocols and preparation of the final reports. Validation activities must be performed in accordance with GMPs.
  • Transfer of analytical methods from/to client/contractor laboratories.
  • This includes the preparation and execution of protocols and preparation of the final reports.
  • Routine calibration and maintenance of analytical instrumentation including, but not limited to, HPLC, HPLC-MS, GC, and GC/MS.
  • Preparation of new documents (SOP’s, specifications, etc) as required.
  • Trouble shooting as required by the Analytical Department

REQUIREMENTS:
We are looking for someone who will:

  • Assume a leadership role in the laboratory by being a useful resource for both analytical knowledge and regulatory information.
  • Develop methods that are rugged and robust.
  • Act as a role model with respect to work ethic, dedication, integrity, and attention to details.
  • Recognize the need for urgency in their responsibilities and makes attempts to meet all requirements and deadlines.
  • Have good communication skills and be able interact productively with clients as needed.
  • Work well with others in the group and other departments.

ACADEMIC/EXPERIENCE REQUIREMENTS:

  • Chemistry Degree with an emphasis on analytical chemistry, PhD preferred.
  • Experience equivalent to 5 – 7 years in pharmaceutical analytical development with knowledge of and experience working in cGMP environments.
  • Thorough understanding of analytical testing and instrumentation including a solid knowledge of chromatographic principles.
  • Knowledge of Quality by Design (QbD) principles, as it pertains to method development, is a plus.

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