Job description

We're looking for a Scientist to join our outstanding firm. The successful candidate will serve as Analytical Scientist for Research and Development, and you will report directly to the Head of R&D. The incumbent will be responsible for the development and optimization of analytical methods used for solid oral modified release drug products for pre-clinical and clinical development, and also testing using these methods for product development at different stages. In this role, the candidate will work with a cross-functional product development team including formulation development and clinical development to develop methods for formulations with a good safety profile and potency in vitro and in vivo. Will also support filings of INDs and NDAs. Your responsibilities will include but not be limited to

• Development of methods for novel formulations to support product development.
• Design experiments to conduct science-based method optimization, and validation.
• Set up and maintain the analytical lab and all related instruments, including HPLC, GC, and dissolution apparatus.
• Support formulation development on release profile and stability.
• Summarize results, prepare development reports, and present data to the product development team.
• Partner closely with colleagues conducting product evaluations, draft specifications, PK/PD, and in vitro and in vivo studies.
• Provide analytical expertise and insights to various interdisciplinary teams.
• Perform analytical method transfer to process development teams or CMO and provide troubleshooting when needed
• Prepare submission materials for INDs and NDAs

Job Types: Full-time, Contract

Pay: $65,640.31 - $138,087.90 per year

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Parental leave
• Relocation assistance
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• San Diego, CA 92121: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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