Overview

With no supervision, serve as study director/principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects. Troubleshoots Wet Lab LM Bioanalysis assays issues and assist in training of LM analysts on wet lab LM systems. Participate as LM representative on first client interaction calls with BD team. Can communicate; write responses to QC/QA findings. Communicate with Clients on specific projects that they are responsible. Accountable for accurate data submission and on time delivery of assigned projects.

Responsibilities

• Extensive research experience in large molecule bioanalysis such as PK, biomarker, immunogenicity. Cancer research experience using flow cytometry and molecular biology techniques is required. Knowledge and experience of large molecule bioanalysis processes and related bioanalytical techniques such as ELISA, PCR, IHC, call-based assay, enzyme activity assay, automation, etc. Proven track record of analytical method development.

• Strong project management and problem solving skills. Serve as a PI to independently design and perform large molecule pharmacokinetics, immunogenicity (ADA and Nab), biomarker, and enzyme kinetic analysis method development, validation and sample analysis.

• Initiation of new research areas and project in large molecule bioanalysis including instrumentation acquisition, set up, scientist training, study design, conducting experiments, method development, optimization, validation and troubleshooting, etc.

• Highly skilled in conducting research, bioanalytical analysis and data interpretation, protocol and report writing, verbal and written communication. Good communication skills with clients, vendors, coworkers, and supervisors are essential. Well organized and detail orientated. Able to handle multiple projects in a fast paced environment, meet project quality and timeline.

• Collaborate with other scientists in team to support large molecule studies. Train junior and peer scientists on various techniques, notebook and raw date documentation, conducting experiments, data processing and interpretation. Supervise junior scientists.

• Follows company’s safety policies, practices and procedures in order to maintain a safe work environment.

Qualifications

• Ph.D. degree in immunology, cell biology, molecular biology, pharmacology or equivalent

• 2-4 years of relevant experience, or equivalent, is desirable

• Any similar combination of education and/or work equivalent experience

Knowledge / Skills / Abilities:

• Knowledge and experience of Good Laboratory Practices (GLP) is a plus. Relevant industrial experience will be an advantage.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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Job Locations US-NJ-Plainsboro

Job ID 2024-12668