Core Competencies:
· Strong skills to lead, motivate, train, and develop staff in analytical R&D group.
· Experience on the characterization of oligonucleotide, antibody-conjugate, and liposomal 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.
· Extensive experience with CMOs and CROs are highly desired.
Responsibilities:
· Lead and oversee the Analytical Team for the physico-chemical characterizations, method development, qualification/validation, and transfer to CMOs or CROs.
· Provide analytical support for internal discovery, development, and stability programs.
· Monitor analytical activities in CROs/CMOs to support siRNA drug substance and liposomal drug product pipelines.
· Author relevant CMC sections for IND/NDA filings. Addresses technical inquiries from regulatory agencies to support preclinical and clinical studies.
· Write standard operating procedures, analytical test methods, protocols/reports for various analytical projects, or stability reports, when required.
· Provide subject matter expertise in analytical support of manufacturing campaigns for GLP and GMP programs.
· Conduct Technical audit to CROs and CMOs. Involve in CROs /CMO selection and technical transfer.
Education and/or Experience:
· Post graduate academic qualifications (M.S. or Ph.D. preferred) in Analytical Chemistry or related scientific discipline with a minimum 10 years of 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.
· Expertise in impurity analysis and separation science such as HPLC, LC-MS, GC, including special chromatographic techniques (SEC, IEX, RPC, HILIC), spectroscopic techniques (UV-vis, fluorescence, FTIR), as well as, product release testing (bioburden, endotoxin).
· Proven track record of managing CROs/CMOs is must.
· Experience in oligonucleotides, and/or lipid, and/or antibody-conjugate based drug products is a plus.
Physical Job Requirements:
Office/Lab environment. Lifting up to 20 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
Disclaimer: The duties and responsibilities of position may change as need arises. The employee will be notified of the change. Relevant work experience may also be substituted for education or certification, at company’s discretion.
Please send your resume to: NittoHRWest@nitto.com
