Process Development Principal Scientist
$141,836–$191,897 year
On-siteThousand Oaks, California, United States
Job Summary
Develop innovative functional area strategies and execute Design of Experiments (DOE) studies to support late-stage and commercial drug product programs. Lead Drug Product Teams, representing the DP function across Product Development, Quality Assurance, Regulatory Affairs, and Clinical Development to advance assets through commercial formulation and post-launch maintenance. Provide technical expertise on the structure, reactivity, and physicochemical properties of drug substances and excipients while mentoring and supervising scientists. Summarize experimental results in technical documents, regulatory filings, and presentations, and engage with external industry groups and academic partners.
Required Qualifications
- Doctorate degree PhD OR PharmD OR MD
- Operations experience
- Master's degree and 5 years Operations experience
- Bachelor's degree and 7 years Operations experience
Desired Qualifications
- Ph.D. in a relevant scientific field, such as Organic Chemistry, Physical Chemistry, Chemical Engineering, Materials Science, or Pharmaceutical Sciences
- Strong scientific foundation with deep understanding of organic molecules and their assemblies
- Strong scientific acumen in organic chemistry, physical chemistry, solid-state chemistry, and the physicochemical properties of small molecules
- Pharmaceutical industry experience, preferably with oral solid dosage forms
- Proficiency with characterization techniques, including XRPD, DSC, TGA, SEM, and related methods
- Knowledge of patent application processes and related legal frameworks is advantageous
- Proven experience in authoring relevant sections for market applications and responding to questions from the agency
- Experience mentoring and developing team members
- Comprehensive understanding of unit operations used to manufacture oral solid dosage forms
- Ability to design, execute, and complete independent formulation research
- Demonstrated record of scientific publication and research dissemination
- Proven ability to collaborate effectively across cross-functional teams
- Exceptional technical writing skills with strong attention to detail
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