Analytical Development Scientist, CMC

San Diego, CA

  • Samumed is seeking a motivated and talented scientist to join the Analytical Development Group in the CMC department.
  • The Analytical Scientist will be responsible for conducting complex chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples by internally developed and compendial test method.
  • Tests methods will be transferred to partner contract manufacturing organizations (CMOs) and the analytical scientist will review the data for accuracy and complete technical result summaries.
  • Drug product and drug substance methods will be developed for phase 1-3 and commercial.
  • Experience providing oversight of analytical research outsourced to third party vendors is preferred.

Specific Responsibilities

  • Conducting chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples
  • Verifying and processing analytical data
  • Participating in the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, spectroscopy, and traditional quantitative analysis
  • Maintaining and troubleshooting analytical instrumentation as needed
  • Clearly and accurately communicating the results of work by creating documentation of the testing/analysis and obtained results. Recording and reporting analytical results in accordance with prescribed lab procedures and systems
  • Maintaining and organizing work area, instrumentation, and testing materials.
  • Performing all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
  • Collaborating with key CMOs to transfer analytical methods
  • Tracking results from CMOs and generate summary reports, highlighting any OOS or trending results

Requirements

  • Bachelor’s degree in a physical science, with 3+ years of experience working in analytical development in the pharmaceutical or biotechnology industry.
  • Excellent knowledge and understanding of chemistry and analytical instrumental technologies.
  • Excellent knowledge of qualitative and quantitative chemical analysis.
  • Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
  • Excellent problem-solving skills and logical approach to solving scientific problems.
  • Excellent proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development and validation).
  • Excellent interpersonal and communication skills (both oral and written).
  • Good presentation skills to present information to customers, clients, and other employees.
  • Ability to read, analyze, and interpret technical procedures and governmental regulations.
  • Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
  • Motivated self-starter.
  • Positive, adaptable, can-do attitude.
  • Ability to work independently.
  • Ability to travel and work flexible hours as required.
  • Proven ability to collaborate in a team environment and work independently
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.