Formulation Process Scientist - Sr. or Staff level
Position: Formulation Process - Sr. Scientist or Staff Scientist
Reporting To: Associate Director, Pharm R&D, Pharm Sciences
Nitto BioPharma, Inc. (NBPI) has one immediate opening for a highly motivated and innovative Sr. Scientist or Staff Scientist to join our location in San Diego, CA. This position seeks a candidate has broad knowledge and experiences in drug delivery, formulation concepts, development strategies, technology transfer, process optimization, and regulatory CMC, in support of NBPI pre-clinical and clinical programs. The individual will play a critical role as the technical/project lead in Pharmaceutical R&D and Pharmaceutical Sciences Team.
Essential Job Requirements
- Ph.D. in Physical/Chemistry, Chemical Engineering, or related fields with >1-year industrial R&D experience, or Master Sc. degree with >3 years, or Bachelor Sc. Degree with >5 years.
- A highly motivated and self-driven individual with ability to work independently to support cross-functional teams and corporate objectives.
- Have hands-on knowledge of Design of Experiments (DOE), parenteral drug development, drug delivery systems (DDS), tech transfer, and CMO manufacturing coordination.
- Takes initiatives and independently accomplishes technical studies, and presents results.
- Strong problem-solving skills and sound judgment in decision-making.
- Effective English communication skills (verbal and written).
- Preferably familiar with liposomal, siRNA/mRNA, lipid nanoparticles development and QbD concepts.
- Previous scale-up manufacturing project experience or DOE software experience a plus.
Duties and Responsibilities
- Design/execute lipid nanoparticles formulations to support cross-functional activities.
- Conduct product characterization, process optimization, tech transfer, and pilot production.
- Identify/evaluate key quality attributes and process parameters for project/product recommendations.
- Author technical reports and CMC sections for IND filing.
- Maintain excellent laboratory records, and write reports and research summaries as required
- Interact closely with other team scientists to develop comprehensive solutions.
- Participate in intellectual property creation.
- Foster a high quality of work, integrity, teamwork, and open/inclusive communication.
- Survey and recommend CMO/CDMO for clinical drug product manufacturing.
- Travel to CMO/CDMO for the oversight of activities and manufacturing may be required. (up to 10%)
Physical Job Requirements:
Office/Lab environment. Lifting up to 30 pounds may be required. Mandatory Covid-19 vaccination policy in effect. 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, 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.
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.