Position description
Summary:
We are seeking a highly motivated and detail-oriented Senior Associate Scientist (Contract) to join our Polysaccharide team. Primary responsibility for the incumbent will be to support analytical testing and characterization of polysaccharide-based drug candidates. This individual will execute and optimize a variety of biochemical and chromatographic assays, contribute to method development initiatives, and ensure high-quality data generation in support of research and development programs.
This role requires strong hands-on experience in HPLC-based techniques, biochemical assays, and analytical software platforms, along with a commitment to data integrity, documentation excellence, and cross-functional collaboration.
Essential Functions:
Analytical Testing & Characterization
- Perform in-house assays for polysaccharide manufacturing, including in-process testing, process development and process characterization study sample analysis, including:
- HPLC-based assays (e.g., HPLC-RI, HPAEC-PAD, etc.)
- Spectrophotometric-based assays (e.g., UV/Vis, Lowry, PicoGreen, Anthrone, etc.)
- Enzyme- and/or Immuno assays (e.g., ELISA, MSD platforms)
- Nephelometry (e.g. Turbidity analysis)
- Metabolite Analysis (e.g. sugars)
- LC-MS-based assay
- Prepare samples, reagents, standards, and controls according to established protocols.
- Troubleshoot instrumentation and assay performance issues to ensure reliable data output.
Method Development & Optimization
- Assist in developing, qualifying, and optimizing analytical methods for sample preparation, testing, and characterization.
- Support method transfer, robustness evaluation, and documentation updates.
- Proactively recommend improvements to increase assay sensitivity, reproducibility, and throughput.
Data Analysis & Reporting
- Utilize data analysis software platforms such as Empower and Chromeleon for HPLC data acquisition and analysis, and SoftMax Pro for MSD and spectrophotometric assay data analysis.
- Analyze, interpret, and summarize experimental data clearly and concisely.
- Prepare technical summaries and present findings to cross-functional teams (e.g., R&D, CMC, Quality).
Compliance & Documentation
- Maintain meticulous laboratory notebooks and electronic records in compliance with internal SOPs and laboratory standards.
- Ensure data integrity and adherence to applicable regulatory guidelines (e.g., GLP/GMP where applicable).
- Participate in audits, documentation reviews, and quality initiatives as needed.
Collaboration & Continuous Learning
- Collaborate effectively with scientists across disciplines to support program milestones.
- Demonstrate eagerness to learn new analytical techniques and scientific concepts.
- Integrate best laboratory practices and contribute to a culture of operational excellence.
Requirements:
- MSc in Chemistry/Biochemistry, Biotechnology, or similar degree with a minimum of 3 years of relevant industry experience, or BSc with a minimum of 5 years of relevant industry experience.
- Hands-on experience with HPLC systems and carbohydrate or polysaccharide analysis.
- Experience with HPAEC-PAD is preferred.
- Experience with LC-MS/MS is a plus.
- Experience with Empower and/or Chromeleon software.
- Familiarity with biochemical assays (ELISA, colorimetric, fluorescence-based assays).
- Experience working with polysaccharides, biologics, or complex drug substances.
- Experience in in-process monitoring and testing for process-related impurities.
- Knowledge of regulatory expectations for analytical documentation.
- Experience supporting CMC, process development, or analytical development programs.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving skills.
- High attention to data accuracy and reproducibility.
- Ability to manage multiple priorities in a fast-paced environment.
- Collaborative team player with proactive communication style.
- Continuous improvement mindset.
Reports to: Senior Scientist, Polysaccharide Analytical Development
Location: San Carlos, CA
Expected Contract Length:
12months
Hourly Range: $56.00/hr. - $62.00/hr.