Role Summary
Associate Scientist (Clinical Assay) to develop and conduct immunological assays for vaccine clinical development in a GMP-like environment, adhering to Good Clinical Laboratory Practice (GCLP). The role includes data analysis, troubleshooting, and data review, enabling safe and effective clinical research. You will collaborate with cross-functional teams, maintain equipment readiness, and organize work to meet deadlines while supporting assay operations and training.
Responsibilities
- Develop and conduct immunological assays to support vaccine clinical development, adhering to Good Clinical Laboratory Practice (GCLP) requirements.
- Present progress on assay development and sample analysis to colleagues and senior management.
- Collect and analyze data to support troubleshooting, qualification, and other lab projects.
- Provide critical data review of both clinical and nonclinical data.
- Execute sample testing and analysis for toxicology and clinical trials.
- Build team skills and collaborate effectively within the work group.
- Stay current on all departmental and corporate training.
- Organize work to meet deadlines and apply technical skills.
- Maintain a detailed inventory of freezer reagents, including controls, proficiency panels, toxins, and reference standards.
- Ensure timely preventive maintenance and proper care of qualified laboratory equipment, coordinating service requests, documenting activities, and maintaining equipment readiness to support uninterrupted assay operations.
Qualifications
- Required: BA/BS with 0 to 2 years of experience with laboratory in a relevant field of science, acquired in academic/industrial setting.
- Required: Proficiency in computer skills, including word processing, Excel, PowerPoint, and relevant scientific software.
- Required: Ability to collaborate and work effectively in a team environment.
- Required: Strong problem-solving skills.
- Required: Excellent communication skills.
- Required: Strong attention to detail.
- Required: Strong organizational skills.
- Required: Ability to work independently and as part of a team.
- Required: Ability to manage multiple tasks and projects simultaneously.
Skills
- Nice to Have: Pharmaceutical and biotech drug discovery experience.
- Nice to Have: Experience in a BSL-2 laboratory environment, including handling virus in compliance with biosafety and regulatory guidelines.
- Nice to Have: Experience in developing and troubleshooting bioassays designed to assess antibody functionality.
- Nice to Have: Proficiency in Microsoft Excel, including data organization, formula creation, pivot tables, and charting.
- Nice to Have: Skilled in GraphPad Prism and Excel to analyze, visualize, and clearly communicate complex biological data.
- Nice to Have: Experience with laboratory robotics and automated liquid-handling systems.
- Nice to Have: Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving.
Education
- BA/BS in a relevant field; 0–2 years of laboratory experience in academic or industrial settings.
Additional Requirements
- Physical/Mental: Work is primarily performed at the laboratory bench or at an office desk using a computer; lifting up to 20 pounds.
- Non-standard Work Schedule: May require occasional weekend and evening work to meet critical business timelines.
- Work Location: On Premise.