Scientist I/II, Analytical Development

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Scientist I/II to work for a leading San Diego biotechnology company.


Scientist I/II, Analytical Development


SUMMARY: 
Perform analytical bench work related to method development, optimization, transfer, qualification, and validation to meet GMP requirements. Duties will also include writing the associated methods, protocols, and reports. Provide technical analytical support to late-stage and commercial products. As a senior member of the lab staff, this position will also provide guidance, advice, and training to junior lab chemists. 
 
RESPONSIBILITIES: 
  • Conducts experiments requiring proficiency in a broad range of experimental techniques and analytical methods, including HPLC, GC, GPC, and various methods for polymer characterization. 
  • Must have extensive experience with LC/QTOF and other mass spectrometric based hybrid techniques 
  • Design and perform experimental studies to support regulatory filings such as identification of unknown degradants. 
  • Performs method optimization, transfer, qualification, and validation at the bench to support new and existing projects. 
  • Writes protocols for analytical method transfer, qualification, and validation and prepares detailed written reports of findings resulting from the execution of those protocols. 
  • Participates in problem solving activities with staff in other departments at Heron and with CMOs and CTLs. 
  • Provides technical support for products in commercial distribution. 
  • Conducts laboratory investigations on aberrant results as needed.
  • Troubleshoots assays and equipment failures as needed.
  • Supports efforts of junior analysts. 
 
REQUIREMENTS: 
  • Bachelors’ degree in chemistry or a related scientific discipline with 7+ years related GMP laboratory experience, or a Master’s degree with 4+ years’ experience, or Ph.D. with a minimum of 3 years’ experience.
  • Experience with a wide range of analytical techniques including but not limited to HPLC, LC/MS, GC, physical testing methods, and compendial test methods relating to small molecules.
  • Demonstrated experience in independent method development. 
  • Experience with raw material/excipient/API qualification and testing. 
  • Working knowledge and experience with cGMP and ICH guidelines. 
  • Excellent analytical, technical writing and data management skills. 
  • Excellent oral and verbal communication skills. 
  • Flexible self-starter with the ability to work independently or with co-workers and multi-task under aggressive development timelines. 


  • Location: San Diego
  • Type: Permanent
  • Job ID: SH353435921