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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