Staff Scientist or Sr. Scientist, Pharm R&D NBPI024
Company: Nitto BioPharma, Inc
Location: San Diego
Posted on: September 15, 2019
, 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.: Description Company Overview: Nitto 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. Clinical assets include a
liver fibrosis program (BMS-986263/ND-L02-s0201), partnered with
BMS and in Phase 2 in the US, an Idiopathic Pulmonary Fibrosis
program (ND-L02-s0201) in Phase 2 in the US and Europe and Oncology
program (NBF-006) in Phase 1 in the US . Nitto BioPharma is also
advancing several programs for intractable diseases including
Oncology and fibrosis.
Keywords: Nitto BioPharma, Inc, San Diego , Staff Scientist or Sr. Scientist, Pharm R&D NBPI024, Other , San Diego, California
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