Scientist I, CMC Analytical Development

$104,000 - $114,400/Yr

Tandym Group - South San Francisco, CA

Full-time - Entry Level

South San Francisco, CA

Administrative and Support Services

About the position

The Scientist I position in CMC Analytical Development at a pharmaceutical company in South San Francisco involves developing and validating physiochemical analytical methods for both early and late-stage molecules, particularly for orphan diseases. The role requires collaboration with various teams to support process and formulation development, ensuring timely testing and release of materials for clinical activities.

Responsibilities

• Develop analytical methods and support extended characterization studies for biologics-based therapeutics.
• Support process and formulation development by providing analytical testing results.
• Work closely with team members in analytical development and quality control, as well as other functions such as Manufacturing, CMC team, Project Development, and Regulatory, to ensure timely development, validation, testing, and release of materials.
• Author and review protocols, technical reports, and method SOPs.
• Contribute to laboratory and manufacturing investigations, developing and executing experiments in the laboratory as needed.
• Collaborate effectively with other functions, including process development, manufacturing, quality control, quality assurance, and regulatory affairs.
• Maintain lab safety, lab equipment, and reagents.
• Perform other duties as needed.

Requirements

• PhD & 2+ years of experience; or, Master's Degree & 4+ years of experience; or, Bachelor's Degree & 6+ years of relevant industry experience.
• Experience with HPLC/UPLC's, CE, and iCIEF analytical methods and instrumentation.
• Experience with state-of-the-art analytical technologies for biologics, such as HPLC (various modes and detections), CE-SDS, icIEF, LC-MS, peptide map, glycan map, disulfide map, DSC, FT-IR, CD, fluorescence spectroscopy, and particle analysis.
• Self-motivated with high attention to detail, ability to analyze, summarize, and present data and significant conclusions to key stakeholders and decision makers.
• Excellent written and verbal communication skills.
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
• Ability to engage collaboratively with CMC functions and external testing laboratories.