Associate Director, Analytical R&D

Location
92121, San Diego
Posted
May 02, 2018
Required Education
Doctorate/PHD/MD
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

 

Responsibilities:

  • 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.

 

Requirements:

  • 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.