Job Overview:
Our company Niviron Inc. connecting with cancer immunotherapy. The company specializes in oncolytic viruses. Our main goal is to increase the duration and quality of life by promoting new technologies aimed at the treatment of oncological diseases to the market. Join us & be a part of this life-saving work!
Looking for a self-motivated, energetic individual to lead a team of individual to develop assays and analyze study sample in support of customers’ drug development programs. Responsible for the development of assays using immunoassay methods, including ELISA, MSD, Cell based assays and others, in support of regulated pre-clinical and clinical bioanalytical studies for drug development programs.
| · Able to lead and direct scientific work to support external methods and projects. |
| · Ensures client programs meet, client, and regulatory requirements. |
| · Develops and reviews protocols and sample analysis plans. |
| · Reviews data with the method development team to ensure methods are ready for validation. |
| · Approves validation methods and reviews sample analysis methods. |
| · Independently reviews and approves raw data.
· Serves as a SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies as applicable. |
| · Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met. |
| · Reviews and approves reports for scientific accuracy and completeness. |
| · Provides technical support as needed. |
| · Assists with efforts to troubleshoot and solve assay problems. |
| · Recognizes the functions of different teams within and seeks guidance when appropriate. |
| · Participates in scientific investigations. |
| · Approves QA project specific inspections. |
| · Approves data archival. |
| · Serves as the scientific point of contact for the client. |
| · Works with the client to determine project requirements. |
| · Gives scientific directives to the study team. |
| · Identifies scientific issues or scope changes within the study. |
| · Communicates and monitors scientific expectations with scientific staff and clients. |
| · Proactively identifies ways to increase client satisfaction. |
| · Promotes quality within the study team. |
| · Provides a technical resource for less experienced team members. |
| · Actively promotes collaboration within and across groups. |
| · Provides appropriate coaching and recognition to team members. |
| · Promotes a positive impression of internally and within the industry. |
| · Able to plan, prioritize, and manage workload for large and complex projects. |
| · Demonstrated ability to manage high volume study work for key clients. |
| · Takes accountability and demonstrates responsibility regarding scientific study conduct. |
| · Good knowledge of client requirements. |
| · Manages time effectively. |
| · Performs other related duties as assigned. |
Education/Qualifications:
Masters (MS) degree in science or related field
Experience may be substituted for education
Experience:
3-4 years of experience in the job discipline
Excellent communication and interpersonal skills
Proven ability to prioritize and manage time
Excellent attention to detail
Able to utilize word processing, database, spreadsheet, and specialized software
Experience and skill with Watson, Nautilus, and Analyst preferred
Knowledge of regulatory agency guidelines
