Scientist, CMC

San Diego, CA

  • The Scientist, CMC will be responsible for supporting API and drug product development, from discovery through commercialization.
  • This individual will develop analytical methodology and drug product dosage forms, and execute complex chemical and physical testing of API, raw materials, finished products and stability samples with minimal guidance.
  • They will interact closely with contract manufacturing organizations (CMOs), ensuring successful knowledge transfer, data and documentation is comprehensive & accurate, and troubleshoot technical challenges.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Conducting chemical and physical testing of pharmaceutical active ingredients, raw materials, finished products, and stability samples.
  • Preparing preclinical solid, liquid, semi solid and suspension formulations for parenteral, oral, topical, and pulmonary delivery.
  • Conducting experiments with clear planning by maintaining organized data records and summarizing results in detailed reports in accordance with prescribed lab procedures and systems.
  • Maintaining and organizing electronic notebook and instrumental raw data records.
  • Processing, reviewing, compiling, and verifying data & batch documentation.
  • Tracking and trending results from CMOs and generate summary reports. Highlighting and investigating OOS and OOT results.
  • Participating in the validation of test methods for pharmaceutical active ingredients & intermediates, raw materials, in-process control and finished products both in house and alongside CMOs.
  • Maintaining and troubleshooting laboratory instrumentation as needed.
  • Maintaining and organizing work area, instrumentation, and testing materials. Organize and resupply CMO’s inventory needed to test Biosplices products as needed.
  • Performing all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
  • Work collaboratively with quality, regulatory, discovery and commercial to meet project goals. 
  • Writing 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 technical experience in the pharmaceutical or biotechnology industry.
  • Excellent knowledge and understanding of chemistry analytical instrumental technology and formulation support.
  • Motivated self-starter and discipline to work independently with minimal guidance.
  • Experience with method development and validation within ICH and USP guidelines.
  • Excellent proficiency with HPLC, PSD, GC, LC/MS and Dissolution techniques, and common analytical software (i.e. Chemstation, Empower, Mastersizer).
  • Experience with solid state techniques such as XRPD, DSC, TGA
  • Experience with preparation and characterization of solid/liquid oral and topical formulations as well as sterile parenteral formulations and aseptic techniques.
  • Excellent understanding of quality and regulatory requirements in the pharmaceutical industry pertaining to ICH, GMPs and USP guidance and standards.
  • Excellent oral and written communication and presentation skills to accurately and clearly share information across all levels of scientific colleagues and CMO staff.
  • 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@biosplice.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.