Senior Analytical Scientist/Principle Analytical Scientist

Reference IDMed006
Specific Duties and Responsibilities:
Our growing R&D lab is looking for Senior talented Analytical Scientists / Principle Analytical Scientist to join our group. 

Responsibilities include:
  • Lead analytical development of parenteral formulations in a product development environment. 
  • Act as a Subject Matter Expert for chromatograph techniques such as HPLC, GC, TLC, IC, LC-MS, and GC-MS. 
  • Lead different wet chemistry testing. 
  • Responsible for leading all analytical aspects of a project while working with other functional areas to advance projects through the pipeline.
  • Lead API and finished product related method development, optimization, validation, and release and stability testing. 
  • Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
  • Responsible for all aspects of Analytical Development and Validation including transfer to Quality Control or other testing laboratory.
  • Evaluate thoroughly DMF for different APIs for completion of analytical methods and lead discussions with API manufacturers to evaluate analytical method package. 
  • Support corporate quality and continuous improvement process. 
  • Write protocols, methods, standard operation procedures, and submission documents independently. Design experimental studies and write reports with minimal supervision.
  • Supervisor CRO work to ensure corporate quality is maintained and activities are performed on timely manner. 
  • Maintain through knowledge of ICH conditions, USP method development, validation, and verification requirements. 
  • Accurately records experimental procedures, test results, and observations to meet GMP requirements.
  • Maintain experimental records, procedures to meet cGMP requirements. 
  • Participate in the review process for appropriate department SOPs, study protocols, and reports.
  • Participate in the training of incoming laboratory staff.
  • Participate as needed in departmental efforts directed toward equipment maintenance, calibration, and qualification.
  • Author various sections in Chemistry, Manufacturing and Control (CMC) document for Regulatory submission. 
  • Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule. 
  • Provide crucial support to other team members in the conduct of their studies.  

Required Competencies:
Education Minimum / Recommended:

  • Ph.D. in Chemistry or other related field with 3+ years’ experience 
  • MS in Chemistry or other related field with 5+ years’ experience 
  • BS in Chemistry or other related field with 7+ years’ experience 

Work Experience Required:

  • Minimum 3 to 7 years of experience is required.
  • Experience working with oncology products is a strong plus.

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