San Diego, CA 92121 US
The incumbent will perform & coordinate developmental/experimental activities to support R&D activities in the research, preclinical 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.
- Duties will include, but 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 expertise and proficiency in parenteral drug product development.
- Sustains knowledge of formulation, 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. 3-5 years) 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 a highly meticulous laboratory approach.
- 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 20 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