Associate Scientist, Analytical R&D NBPI031
Position: Associate Scientist, Analytical R&D
Reporting To: Director, Chemistry & Analytical
• Strong ability to apply scientific principles and critical thinking towards recognizing and solving pertinent problems is essential.
• Effective communication skills (oral, written, presentation).
• Able to plan and coordinate daily activities to align with department priorities/timelines and efficiently deliver on expectations.
• Hands-on experience in analytical chromatography or oligonucleotide characterization.
• Familiarity with cGMPs/GLPs and relevant regulations (ICH, FDA, EU) is a plus.
• Strong preference is given to individuals experienced in routine cleaning, maintenance, and performance verification for HPLC systems and related hardware.
• Must be proficient in basic software applications, including Microsoft Office.
• Demonstrated experience with one or more scientific software applications is required.
• Performs routine analyses in support of chemistry, formulation, and biological research studies.
• Provides testing support for method development and method validation.
• Ensures data integrity; including proper documentation of experimental methods, results, and conclusions in laboratory notebooks.
• Performs analytical data review for product stability and release.
• Accurately follows SOPs related to safety, documentation, analytical methods, and corporate policies.
• Maintains assigned laboratory equipment in a clean and safe manner, including routine operation and calibration.
• Generates and/or reviews SOPs, certificates of analysis, analytical reports, and other documents.
• Shows initiative in identifying technical or process improvement opportunities.
• Follows safe laboratory practices according to corporate policies.
• Other work as assigned based on the project and company needs.
Education and/or Experience:
Bachelor’s Degree with 3-5 years experience or M.S. with 2+ years experience in Chemistry, Biochemistry, or related scientific discipline in a field relevant to pharmaceutical analytical development.
Direct experience in at least one of the following:
Liquid chromatography (RP-HPLC, SEC, IEX) for purity/impurity analysis; mass spectrometry experience is a plus.
Bioanalytical method development, including analyte extractions from biological fluids.
Experience working with nucleic acids, proteins, or nanoparticles is a plus.
Physical and Other Job Requirements:
• Office/Lab environment. Lifting up to 50 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.
• 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.
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.
Company DescriptionNitto BioPharma, Inc. is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Nitto BioPharma offers unique RNA drug and its delivery solutions by designing novel biodegradable drug delivery systems with the ability to target specific cells and efficiently deliver the cargo into the cells. Clinical assets include two Phase 2 clinical programs, a first-in-class drug for the treatment of liver fibrosis (with Bristol-Myers Squibb), and idiopathic pulmonary fibrosis, as well as a Phase 1 oncology program to treat non-small cell lung cancer.
Nitto BioPharma's mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation (Nitto), Nitto BioPharma has created a new and efficient business unit that allows pharmaceutical products to be brought to market at a fast pace. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make Nitto BioPharma a vibrant and exciting work environment.
Nitto BioPharma is a key asset of Nitto. Since its establishment in 1918, Nitto has created over 13,500 products based on its core technologies and has contributed to customers' value creation with innovative ideas. The core of Nitto's life science business consists of contract manufacturing and drug discovery.