Associate Director, Analytical R&D

New
  • Location
    San Diego, California
  • Job type
    Direct Hire
  • Salary
    $ 150000 - $ 175000 / Hour
  • Category
    Engineering - Scientist

Our client is a global biopharmaceutical company and is hiring an Associate Director of Analytical R&D to work on-site at their San Diego location. Please review the requirements below and apply if interested and qualified for more information!

Requirements:

Ph.D. in Analytical Chemistry or related scientific discipline
10 + years of analytical development experience in the pharmaceutical industry.
Strong 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).


Experience in oligonucleotides and/or lipid based drug products is a plus.


Responsibilities:

Monitor analytical activities in CROs/CMOs to support siRNA drug substance and liposome drug product pipelines.
Author relevant CMC sections for IND/NDA filings. Addresses technical inquiries from regulatory agencies to support preclinical and clinical studies.
Lead the Analytical Team for the physico-chemical characterizations and bioanalytical method development, qualification/validation, and transfer to CMOs or CROs.

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.



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Reference number US_EN_2_108175_329428