Formulations Scientist (Sr. Scientist I)

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Job description

Job Description

Position: Formulation Scientist (Senior Scientist I)

location: San Diego, CA

Reporting To: Director, Formulation

Position Objective

The incumbent will perform & coordinate developmental/experimental activities to support R&D activities within the research department, supporting new formulation and process development. Will be a member of the extended project team and contribute in the lab as well as in technical documentation of activities, both in a notebook and online technical reports.

Major Job Functions

• Designs and executes formulation, compatibility, and process studies to support phase appropriate development of NBPI's drug product portfolio.

o Duties will include, but are not limited to, design of programs, evaluation of data, recommendations on strategy, and authoring reports.

• Prepares technical reports and makes recommendations to senior management based on research outcomes.

• 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, integration, and teamwork.

• Sustains knowledge of formulation and process development.

• Sustains written and verbal communication skills to effectively interface across functional teams and present technical concepts and results.

• Sustains ability to identify and resolves critical issues; implement technical and operational plans.

• Sustains problem-solving skills and demonstrate good judgment and decision-making experience.

Education, Licensure and/or Experience

• Academic qualifications: Ph.D. with 3-5 years' experience in chemistry, bioengineering, chemical engineering, or a closely related discipline.

• Formulation and product development experience (5 years) with drug delivery systems, biophysical, and molecular biology techniques.

• Hands-on experience with liposome or nanoparticle drug delivery systems.

• Basic knowledge of GMP and regulatory CMC. You will plan and perform laboratory formulation development and scale up experiments.

• Detail oriented and highly meticulous laboratory approach.

Preferred Qualifications

• Liposomal siRNA/mRNA/miRNA/drug delivery experience.

• Familiarity with stages of the product development and cGMP concept.

• Knowledge of analytical methods for testing lipid nanoparticles.

• Understanding of the in-vitro and in-vivo experiments used for screening for candidate formulation.

• Knowledge of delivery systems incorporating polymers, conjugates and small molecules.

Physical Job Requirements:

Office/Lab environment. Lifting up to 30 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.

Company Description

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. 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.