BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Analytical Scientist to work for a leading San Diego biotechnology company.
An individual at this level will be expected to build and lead a team focused on the development of analytical methods for small molecule and peptide drug products. The main focus will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, and chiral. However alternate detection methods such as ELSD may be employed. In addition, the individual may be responsible overseeing development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products. The individual will assist in the researching and introduction of new analytical technology to characterize drug products. There is an expectation of both direct hands-on laboratory work as well as supervision of 1-3 direct reports and mentoring/training of other colleagues as needed.
- Be independently proficient in a variety of analytical techniques and regulatory areas including, but not necessarily limited to:
- Analytical balances, pH meters, high performance liquid chromatography (HPLC), UV/Vis spectroscopy, USP dissolution testing apparatus, moisture analysis by Karl Fischer, and analytical method validation.
- Experience with disintegration, DSC, TGA, hardness, and friability testing also desired. Methods that are developed within the group will be qualified or validated as appropriate for the stage of development. In addition, the individual may assist in troubleshooting existing methods.
- The individual will be able to communicate results both internally and externally through oral and written updates and formal reports as necessary.
- The individual may be required to assist in the creation and/or revision of company SOPs.
- Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues is expected.
- B.S. in life sciences, ideally Chemistry, Biochemistry, Pharmacological Chemistry or Biology
- 7+ years’ experience in analytical development
- Thorough knowledge and experience in HPLC stability-indicating method development and validation
- Strong oral and written communication
- Previous supervisory experience preferred