Associate Director, Analytical R&D

92121, San Diego
May 02, 2018
Required Education
Position Type
Full time

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for an Assoc. Director to work for a leading San Diego biotechnology company.


Associate Director, Analytical R&D



  • Lead the Analytical Team for method development, qualification/validation, and transfer to CMOs or CROs.
  • Monitor analytical activities in CROs/CMOs
  • Author CMC sections for IND/NDA filings. Addresses technical inquiries from regulatory agencies to support preclinical and clinical studies. 
  • Provide analytical support for internal discovery, development and stability programs.
  • Provide subject matter expertise in analytical support of manufacturing campaigns for GLP and GMP programs.
  • Oversee internal development and transfer methods to CMOs and contract labs
  • Conduct Technical audit to CROs and CMOs. Involved in CROs /CMO selection and technical transfer.



  • Ph.D. in Analytical Chemistry or related scientific discipline with a minimum 10 years’ experience in the pharmaceutical industry for analytical development. 
  • Knowledge and experience in the development and validation of test methods for API and drug product candidates, physic-chemical characterizations, general analytical analysis, assay/impurity analysis, and specifications development.
  • CMC experience with thorough understanding of the regulatory requirements for different phases of drug development.
  • Knowledge of bioanalytical method development, including analyte extractions from biological fluids and related analytical methodologies.
  • Expertise in impurity analysis and separation science such as HPLC, LC-MS, GC, including special chromatographic techniques (SEC, IEX, RPC, HILIC) as well as spectroscopic techniques (UV-vis, fluorescence, FTIR). 
  • Strong skills to lead, motivate, and develop the people in analytical R&D group. 
  • Experience in oligonucleotides and/or lipid-based drug products is a plus.
  • Approximately 10% travel. Possible overtime. 
  • Lifting up to 50 pounds may be required.