Formulation Scientist

Qnovia, Inc.; Newport Beach, Northern (CA, KY); Hybrid; USD 125,000 - 160,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vis

Equity ownership in a pre-commercial/急

Job summary

Qnovia, Inc. seeks a Formulation Scientist to design, develop, and characterize nebulized drug formulations across pulmonary and systemic programs.

You will collaborate with device engineering and clinical teams, inform regulatory submissions, and deliver robust analytical methods for aerosol performance, stability, and solubility enhancements.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemistry, or related field, or MS with 5+ years of relevant experience.
• Experience with inhaled drug product formulation and aerosol characterization.
• Proficiency with cascade impaction (NGI/ACI), laser diffraction, and spray pattern analysis.
• Knowledge of ICH stability guidelines (Q1A–Q1E) and CMC regulatory requirements.
• Experience with HPLC, LC-MS, and other analytical instrumentation.
• Strong scientific writing and data analysis skills.
• Ability to work independently and manage multiple projects simultaneously.

Responsibilities

• Design and execute formulation development studies for nebulized drug products.
• Characterize aerosol performance including MMAD, GSD, output rate, and delivered dose.
• Develop analytical methods for drug content, stability, and degradation products.
• Conduct formulation compatibility studies with device materials and components.
• Support stability program design and execution per ICH guidelines (Q1A–Q1E).
• Author technical reports, protocols, and regulatory submission sections (CMC).
• Collaborate with device engineering and clinical teams on integrated product development.
• Evaluate excipient selection and solubility enhancement for poorly soluble compounds.

Skills

Inhaled formulation

Aerosol characterization

Scientific writing

Data analysis

Independent work

Education

PhD in Pharmaceutical Sciences or Chemistry

MS + 5+ years experience

Tools

HPLC

LC-MS

Cascade impaction (NGI/ACI)

Laser diffraction

Spray pattern analysis

Job description

Develop and optimize drug formulations for nebulized delivery, supporting Qnovia's pipeline of respiratory and systemic therapeutics.

About the Role

Qnovia's platform relies on precisely engineered formulations that are compatible with ultrasonic nebulization and optimized for pulmonary or systemic absorption. As a Formulation Scientist, you will design, develop, and characterize drug formulations across multiple therapeutic areas. Your work will directly inform device design, clinical study design, and regulatory submissions.

Responsibilities

• Design and execute formulation development studies for nebulized drug products
• Characterize aerosol performance including particle size distribution (MMAD, GSD), output rate, and delivered dose
• Develop analytical methods for drug content, stability, and degradation product analysis
• Conduct formulation compatibility studies with device materials and components
• Support stability program design and execution per ICH guidelines
• Author technical reports, protocols, and regulatory submission sections (CMC)
• Collaborate with device engineering and clinical teams on integrated product development
• Evaluate excipient selection and solubility enhancement strategies for poorly soluble compounds

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemistry, or related field; or M.S. with 5+ years of relevant experience
• Experience with inhaled drug product formulation and aerosol characterization
• Proficiency with cascade impaction (NGI/ACI), laser diffraction, and spray pattern analysis
• Knowledge of ICH stability guidelines (Q1A–Q1E) and CMC regulatory requirements
• Experience with HPLC, LC-MS, and other analytical instrumentation
• Strong scientific writing and data analysis skills
• Ability to work independently and manage multiple projects simultaneously

Preferred Qualifications

• Experience with nebulized formulation development (solution and suspension)
• Background in nicotine or small molecule pulmonary pharmacology
• Familiarity with QbD (Quality by Design) approaches to formulation development
• Experience supporting IND or NDA CMC sections

$125,000 – $160,000 annually, depending on experience. Equity participation included.

• Comprehensive medical, dental, and vision insurance
• Equity ownership in a pre-commercial stage company
• Flexible hybrid work arrangement
• 401(k) with company match

Qnovia, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact us at [e-mail].

This job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Qnovia reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.