Job Opportunity
As a senior scientist in immunoassay, you will be responsible for managing your own work while actively contributing to the team.
Key Responsibilities:
* Conduct regulated studies in accordance with GLP/GCP standards and latest regulatory guidelines.
* Develop and validate methods for pharmacokinetic studies and anti-drug antibody studies using ELISA or MSD platform.
* Ensure accurate communication of experiment outcomes and effective problem-solving skills.
* Drive personal development, seek training opportunities, and contribute to process improvement.
* Embody and promote laboratory excellence, maintaining a clean and respectful work environment.
* Collaborate with internal and external clients, management, and scientific staff to build strong working relationships.
Other Key Roles:
* Supervise junior members of the department in the laboratory.
* Develop methods for challenging compounds without supervision.
* Review proposals and highlight concerns to the Team Leader or Business Development.
* Raise the profile of our organization by publishing or presenting research, both internally and externally.
* Maintain regulatory compliance and set a good example for others in the team.
* Ensure audit findings are resolved within the allowed timeframe.
Requirements:
* Ph.D. degree with at least 3 years of experience in immunology, biochemistry, or analytical chemistry, or an equivalent combination of education, training, and experience.
* Technical expertise in ELISA or MSD platform development and validation.
* Knowledge of ICH M10 guidance is a plus.
* Understanding of GLP, GCP, and 21 CFR Part 11 requirements.
* Excellent communication skills (writing and speaking).