- Design and develop formulations and processes for new drug products with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
- Utilize experimental design to rapidly optimize formulation composition and in-process specifications
- Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
- Present product development progress to upper management and project teams
- Write CGMP manufacturing batch record, stability study protocol, in-process and finished product specifications and product development reports
- Manufacture development, optimization and scale-up batches and submission batches
- Troubleshoot formulation issues that occur during RD development, scale-ups and/or in production
- Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
- Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
- Follow relevant Frontida SOP’s and FDA/ICH guidance
- Other duties as assigned
- Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 2 years of experience or a Master’s Degree with 3 years’ experience is preferred.
- Experience with generic drug development is desirable
- Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- High degree of professionalism, ethics and integrity
- Incumbent must be able to be accountable for own actions and decisions and is in compliance with the laws and company policies.
- Willing to participate in our group identity characterized by commitment, trust, and care for each other.
- Willing to invest time and energy in continuous improvement efforts
Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.