Associate Director, R&D
Job Description: Associate Director, R&D
- Strong skills to lead, motivate, and develop the people in analytical R&D group.
- Experience on the characterization of oligonucleotide and liposome drug products.
- Strong knowledge of GMPs/GLPs. CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with ICH and FDA Guidance.
- Experience in analytical method development, validation and transfer.
- Experience with IND authorship.
- Working experience with CMOs and CROs is essential.
- Lead the Analytical Team for the physico-chemical characterizations and bioanalytical method development, qualification/validation, and transfer to CMOs or CROs.
- 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.
- 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.
- This is a professional full time position that may require more than 40 hours per week to achieve project objectives. Approximately 10% travel.
Education and/or Experience:
- Post graduate academic qualifications (Ph.D.) in Analytical Chemistry or related scientific discipline with a minimum 10 years experience in the pharmaceutical industry for analytical development.
- Demonstrate broad 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).
- Experience in oligonucleotides and/or lipid based drug products is a plus.
- Project Management tools