Analytical Scientist I - San Diego
San Diego, CA
We are looking for an Analytical Scientist I to support our Pharmaceutical Development and Manufacturing group. In this role you will support early-stage product development efforts, focusing on analytical method transfer and development activities. Working under the guidance of senior staff, you will perform routine analytical testing, develop or transfer analytical methods, and support equipment identification, purchase and qualification.
- Providing technical support for pharmaceutical product development projects by executing analytical method development and transfer activities. You will troubleshoot and resolve technical issues with methods and use data to determine path forward in resolution. You will serve as a technical contributor and/or independent project team member and proactively communicate with project teams and clients on the technical aspects of the project.
- Performing analytical testing and data peer review for stability, clinical, and analytical method development for new products and processes. You will document test results and lab activities timely and accurately, verifying calculations and completeness of data sets. You will evaluate and interpret test and experimental data, draw conclusions based on results, and transcribe results into analysis reports, and/or stability summary sheets.
- Writing analytical procedures, method development reports, transfer/validation protocols, and evaluation and transfer reports for R&D projects.
- Assisting management with the identification, acquisition, upgrade and qualification of laboratory instrumentation. You will troubleshoot technical issues with instrumentation such as HPLC, LC/MS/MS, and other equipment associated with product development activities.
- Complying with site wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and data integrity and security.
- Either a bachelor’s degree in Analytical/Organic Chemistry or related scientific discipline with 5 years of relevant work experience in a pharmaceutical or related laboratory setting; A master’s degree with 2 years of relevant experience, or a PhD in a relevant science-based field
- We highly prefer candidates with hands on experience with analytical method development activities, experience writing summary reports, test protocols, SOP's and other technical summary reports, and familiarity with analytical techniques for characterization of biologics (i.e. proteins, RNA, DNA).
- Technical knowledge of analytical laboratory methods, techniques, and lab safety procedures relevant to analytical method development, validation and transfer processes, including the use of chemicals, reagents and solutions is required.
- Working knowledge of GLP/cGMP practices and other relevant regulatory guidance is preferred.
- Working knowledge of chromatography data management software (Empower/Chemstation/Open Lab).
- Advanced understanding of chromatographic techniques and basic trouble shooting skills for typical HPLC and other analytical equipment.
- Strong verbal and written communication skills, including technical writing.
- Good interpersonal skills and ability to work effectively in a team environment and with client companies.
- Demonstrates project management skills. Ability to react quickly to changes in project priorities and timelines and to support multiple projects simultaneously.
- Working knowledge of Microsoft Office suite of software (Word, Excel, and Outlook).