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Bioanalytical PI – Neutralizing Antibody and Cell Platform

Negotiable

/per month

Job Responsibilities:

1. As the project leader for bioanalytical projects related to neutralizing antibody and cell-based platform assay development, I communicate with clients regarding project timelines, manage project progress, and resolve technical issues that arise during the project.

2. Appropriately allocate laboratory personnel and coordinate support from operations staff to ensure timely completion of development, verification, and testing activities.

3. As the project’s core technical expert, review the raw data, experimental records, study protocols, and reports for relevant projects to ensure that the entire project—from method development and validation to sample analysis—adheres to scientific rigor and complies with the latest regulatory requirements.

4. Manage the project folder for assigned projects and its associated materials, including bioanalytical data.

5. Ensure compliance for bioanalytical projects, including supporting QA and external regulatory audit inspections, and responding to QA or external audit findings.

6. As the primary point of contact for external communications on related projects, represent the company in liaising with clients on matters such as project initiation, project progress, and technical details.

7. Conduct data analysis, data quality control, and data interpretation in alignment with project requirements.

8. Assist in the training and onboarding of new employees to ensure that their work complies with GLP regulations and SOP requirements.

9. Acquire new technologies through literature review, external learning, and other means to enhance the company’s technical capabilities.

 

Job Requirements:

1. Proficient in the construction of various cell banks, with experience in developing, validating, and implementing cell-based assays for activity profiling, as well as in method development, validation, and assay execution for neutralizing antibody studies; capable of resolving related technical challenges.

2. Ph.D. in molecular biology, pharmacology, or a related biological discipline with 1–2+ years of bioanalytical experience, or a Master’s degree in a similar field with 3+ years of bioanalytical experience.

3. Familiar with GLP-related regulations and have experience undergoing inspections by drug regulatory authorities.

4. Possesses experience in project management and team management.

5. Possesses strong leadership, interpersonal, communication, collaboration, and problem-solving skills.

6. Strong oral and written communication skills, as well as proficient reading and writing in English.

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Laboratory technician

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