Staff Scientist/Principal Scientist, Analytical Chemistry NBPI008

Job Description

Staff Scientist, Analytical/Principal Scientist (NBPI008)

Employer: Nitto BioPharma, Inc

Location: San Diego, California

Ref : NBPI008

Discipline: Science/R&D, Bioanalytical Services, Chemistry, Laboratory

Required Education: Doctorate/PHD/MD

Position Type : Full time

NBPI is looking for a Staff Scientist, Analytical/Principal Scientist to join our Analytical Development department. NBPI is currently developing a Liposome-based pharmaceutical product in clinical stage. This position is responsible for the analytical method development/optimization for the physico-chemical characterizations, implementation, testing/reporting, and methods transfer activities to support drug development from early discovery stage to later clinical phases. Extensive chromatography experience on HPLC-UV/ELSD/CAD/MS is necessary. Experiences in oligonucleotides and lipid analytics are highly desirable.

The level and title will be commensurate with the incumbents experience and work history.

Qualifications:

Required:

• Ph.D. Degree in Analytical Chemistry, or related scientific discipline with 5+ years' experience in pharmaceutical industry with scientific responsibilities in analytical development
• Demonstrate broad knowledge and experience in the development/qualification/validation of analytical test methods for API and drug product candidates, physic-chemical characterizations, general analytical analysis, assay/impurity analysis using a variety of analytical techniques including HPLC-UV/ELSD/CAD/MS, GC-FID/MS, FTIR, UV-Vis Spectroscopy, DLS, SEM/TEM, DSC/TGA, NMR, Powder X-Ray Diffraction.
• Experience in the designing/executing/testing/reporting the stability studies following ICH guidance.
• Strong problem-solving and method troubleshooting skills
• Familiar with USP methods, cGMPs/GLPs and EU regulations, and ICH, FDA CMC Guidance Documents.
• Excellent communication skills (oral, written, presentation).

Desired:

• Working experience on the characterization of oligonucleotide and liposome drug products is a plus.
• Experiences in method validation and method transfer to CROs /CMOs are highly desired.
• Participant in the preparing and reviewing the analytical/stability sections for IND/NDA documents.

Essential Functions:

• Responsible for the analytical method development/optimization to support siRNA drug substance and drug product analysis with minimum or no guidance.
• Perform method qualification, and write qualification protocols and reports. Support method transfer to CRO/CMOs.
• Design and execute stability studies, report and evaluate stability data to support drug development studies from early discovery to later phase of clinical studies.
• Conduct HPLC/UPLC-based assays for siRNAs and liposome, and perform other physico-chemical characterizations of liposome drug product use a variety of analytical techniques.
• Participate in troubleshooting or OOS investigation during the routine sample analysis.
• Generate/review certificates of analyses and analytical reports for product release, quality control or drug development purposes.
• Prepare scientific representation in project meeting to support chemistry, formulation and biological studies. Maintain strong collaborative relationships with members in Biology, CMC, and quality.
• Perform tasks following SOPs, cGMP and GLP regulations, and keep abreast with the latest regulatory quality requirements
• Maintain the laboratory facilities and equipment in a clean and safe manner. Operate, calibrate qualify and maintain general laboratory instruments as needed.

Physical Job Requirements:

• This position splits its time between an office and laboratory environment. Lab work may include the use of centrifuges, microscopes, spectrometers and other laboratory tools. Will be required to wear personal protective equipment and comply with all safety regulations in the lab.
• Software used will include most typical office applications such as word processing and spreadsheets, and may include project management and analytical or scientific technology.
• Works in a team environment, regularly interacting with others in writing, by phone, email, and in person.
• This is a professional full time position that may require more than 40 hours per week to achieve project objectives. Might need ~10% travel.

• Participate in method verification/validation or transfers, with minimum or no guidance.
• Review release and stability data, prepare technical reports, and provide Analytical support for CMC conducted in-house or at CMO locations.
• Act as the point of contact with CROs/CMOs to support multiple stages of drug product development.
• Train junior Research Scientists on HPLC/UPLC-based assays for RNA and lipid materials.
• Conduct laboratory, OOT, and OOS investigations.
• Contribute to the creation/revision of SOPs, COAs, protocols, and reports.

Company Description
Nitto BioPharma, Inc., is a biopharmaceutical company focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Clinical assets include anti-liver and lung fibrosis drug programs, which are now in clinical Phase 2 trials, and lung cancer program, which is in Phase 1 trial. Nitto BioPharma is also advancing several pre-clinical programs for intractable diseases including Oncology and metabolic/fibrotic diseases. Along with the establishment of the new company, in mid-2016 Nitto BioPharma moved into our new R&D facility on Science Center Drive in San Diego, California.