Job Title: Sr. Scientist/Scientist II, Preformulation Sciences
Job Number: 34014
Location: San Diego, CA
In this role, you will play a vital role in both Research and CMC, offering essential formulation support for preclinical candidates as they progress towards development nomination. This person will take the lead in exploring and characterizing the physical and chemical properties of drug substances and products. They will also be responsible for developing preclinical dosing formulations to support early animal studies, conducting thorough polymorph screens, salt screening, and selecting solid forms, including biopharmaceutical evaluation.
- In charge of daily assessment of small molecule pre-formulation and preclinical formulations to advance the discovery programs. Design and execute development studies, including formulation development, analytical characterization, and control of small-scale stability studies. Skillfully interpret study results and suggest follow-up investigations with minimal guidance, leveraging scientific and regulatory expertise.
- Provide support for preclinical formulations, specifically in drug delivery, to ensure the desired pharmacokinetic (PK) coverage in preclinical studies. Investigate and enhance the solid-state phase properties of preclinical drug candidates, encompassing pharmaceutics, stable polymorph identification, and salt selection.
- Collaborate with both internal and external Contract Research Organizations (CROs) to facilitate the progress of discovery projects. Conduct complex experiments efficiently and independently while maintaining meticulous records in accordance with company standards and training.
- Generate innovative hypotheses to advance project objectives and steer new experimental directions. Summarize experimental findings, review and interpret study results, and compile data packages. When necessary, transfer laboratory procedures and methods to external partners.
- Develop inventive solutions to overcome obstacles hindering project goals and stay informed about relevant industry and regulatory guidelines and requirements.
- Perform any other duties as assigned.
- A Ph.D. in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field, with a minimum of 3 years of experience, or a BS/MS degree with over 10 years of industry experience in the development of pharmaceutical preclinical formulations. Possesses a solid foundation in analytical methods and an extensive understanding of pre-formulation for small molecules. Offers a diverse background in various formulation and characterization techniques.
- Has hands-on expertise with instruments like HPLC, LC-MS, PXRD, DSC, TGA, and PSD. Regularly carries out challenging and intricate experiments with success. Demonstrates the ability to function effectively within a fast-paced team environment, handling multiple projects and meeting deadlines.
- Displays strong written and verbal communication skills. Develops, reviews, and approves source documents for regulatory submissions and/or manufacturing. Proven track record of identifying and effectively conveying the technical and compliance aspects of regulatory submissions.
- Exhibits initiative and leverages scientific creativity and insights. Often demonstrates exceptional determination and persistence in supporting projects.
Salary range: $130,000-145,000K annually
Health Insurance (medical, dental, vision)
Short- and Long-Term Disability
Paid Time Off