Director, Analytical Development

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


Director, Analytical Development


Summary:
An individual at the level of Director, Analytical Development will be expected to build and lead a team focused on the analysis of small molecule and peptide drug products. The team will be responsible for supporting early phase development activities such as analytical method transfer, test method development, product testing and phase appropriate validation. Team members will work closely with both formulation chemists as well as Quality Control. Commonly performed analytical techniques will include HPLC, dissolution (discriminating and USP), UV, Karl Fischer titration, DSC. It is anticipated that the team will include 15-20 people once fully staffed.

Responsibilities:
  • Must have proven leadership experience in managing and mentoring analytical chemists at various levels. 
  • Provide strategic input into the team growth plan. 
  • Independently proficient in a variety of analytical techniques and regulatory areas including, but not necessarily limited to: analytical balances, pH meters, HPLC, UV/Vis spectroscopy, USP dissolution testing apparatus, moisture analysis by Karl Fischer, and analytical method validation. 
  • Experience with disintegration, DSC, TGA, hardness, and friability testing also desired. 
  • Methods that are developed within the group will be qualified or validated as appropriate for the stage of development. 
  • Be familiar with current statistical techniques used in method development and validation.
  • Able to communicate results both internally and externally through oral and written updates and formal reports as necessary. 
  • Opportunities to speak or present at conferences may also arise. 
  • Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues is expected.  


Requirements:
  • Requires minimum B.S. in life sciences, ideally Chemistry, Biochemistry, Pharmacological Chemistry or Biology
  • 10+ years’ experience in analytical development in a pharmaceutical setting
  • Proven abilities in leadership and personnel management
  • Knowledge and direct experience with CMC analytical requirements for IND stage drug compounds
  • Able to communicate effectively with clients regarding project scope, scientific results and project updates, including unexpected or negative results and potential delays
  • Strong oral and written communication


  • Location: San Diego
  • Type: Permanent
  • Job ID: BR1382081222