Scientist, CMC

San Diego, CA

  • Samumed is seeking a motivated and talented scientist to join the CMC department supporting analytical and formulation development.
  • The 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 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. Laboratory work will include early stage formulation development and preparation to support preclinical studies.
  • Troubleshoot formulation issues and participate in technical discussions pertaining to formulation design.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Conducting chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples.
  • Preparing preclinical solid, liquid, semi solid and suspension formulations for parenteral, oral, topical, and pulmonary delivery.
  • Processing, reviewing, and verifying data.
  • Maintaining and organizing electronic notebook and instrumental raw data records.
  • Participating in the validation of test methods for pharmaceutical raw materials and finished products both in house and alongside CMOs.
  • Maintaining and troubleshooting analytical instrumentation.
  • Having a hands-on approach to laboratory work including formulation activities.
  • Conducting experiments with clear planning by maintaining organized data records and summarizing results in detailed reports in accordance with prescribed lab procedures and systems.
  • Performing all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
  • Tracking and trending results and generate summary reports. Highlighting and investigating OOS and OOT results.
  • Writing and reviewing technical documents such as technical protocols, reports and test methods as well as SOP’s, COA’s and other relevant controlled documents.

Requirements

  • Bachelor’s degree in a physical science, with 3-7 years or PhD 1-2 years of experience working in the pharmaceutical or biotechnology industry.
  • Excellent knowledge and understanding of chemistry analytical instrumental technology and formulation.
  • Experience with preparation and characterization of solid/liquid oral and topical formulations as well as sterile parenteral formulations and aseptic techniques.
  • Experience with method development and validation within ICH and USP guidelines.
  • Excellent understanding of quality and regulatory requirements in the pharmaceutical industry pertaining to ICH, GMPs and USP guidance and standards.
  • Excellent proficiency with HPLC, PSD, GC, LC/MS and Dissolution techniques
  • Experience with solid state techniques such as XRPD, DSC, TGA
  • Formulation characterization techniques such as viscosity and osmolarity desirable.
  • Excellent oral and written communication skills.
  • Motivated self-starter and discipline to work independently with minimal guidance.
  • Ability to travel and work flexible hours as required.
  • Must be a punctual, reliable, team-player with a positive, can-do attitude 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.