Staff Scientist or Sr. Scientist, Pharm R&D NBPI024

Location
San Diego, CA, United States
Posted
Sep 16, 2019
Ref
6e500f6b
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
, Inc.

JOB DESCRIPTION

Position: Staff or Sr. Scientist, Pharm R&D

Reporting To: Associate Director, Pharm R&D

Core Competencies
  • Sustains expertise and proficiency in parenteral drug product development, such as siRNA or mRNA drugs, from pre-clinical to clinical phases.
  • Sustains hands-on knowledge of formulation, process development, drug delivery (such as Lipid nanoparticle, LNP) systems, CMO management, manufacturing, and regulatory CMC.
  • Sustains written and verbal communication skills to effectively interface across multi-discipline teams and present technical concepts, strategies and scientific results.
  • Sustains ability to identify and resolve critical issues; implements technical studies.
  • Sustains problem-solving skills and demonstrates good judgment and decision-making.


Responsibilities
  • Designs and executes formulation, compatibility, and process studies to support various phase-appropriate development of NBPI's drug product portfolios. Duties will include, but not limited to design of programs, evaluation of data, recommendations on strategy, and authoring reports.
  • Supports technical transfer efforts and/or manufacturing of new or existing products at CMOs. Supports CMOs with the appropriate studies during the development and validation phases of projects.
  • Manages and authors appropriate development reports and other documents for internal use and support of regulatory filings.
  • Supports project activities and collaborates with colleagues in performing formulation, compatibility, and analytical studies as needed.
  • Supports the organization in maintaining a safe working environment focused on quality and that fosters learning, respect, open communication, collaboration, integrity, and teamwork.


Education and/or Experience:
  • PhD degree in chemistry, chemical engineering, pharmaceutical sciences, or related disciplines with a minimum of 2 years' relevant industry experience; or MS with a minimum of 5 years' relevant industry experience as above.
  • Preferably familiar with liposomal development, QbD, and Design of Experiments (DOE) concepts and software.


Physical Job Requirements:

Office/Lab environment. Lifting up to 25 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: This job description reflects management's assignment of essential job duties; and nothing in this herein restricts management's right to assign or reassign duties and responsibilities to this job at any time.

About Nitto BioPharma Inc.:

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.