Senior Research Scientist - ELISA and Immunoassay at PPD in Princeton, NJ
JOB DESCRIPTION PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health! PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD. This position is part of the Immunochemistry and Biomarker Development team at our client site in Princeton, NJ. In this position you will contribute to the development, validation and implementation of immunoassays for analysis of clinical and nonclinical biological samples in a GLP-like environment in support of drug development and filings of INDs, NDAs and other regulatory submissions. Primary responsibility will be support of projects requiring novel methods of biomarker analysis, novel biomarkers, and traditional validated immunoassay methods. A comprehensive understanding of manual methods and immunoassay technologies such as ELISA, ECL (MSD), and Luminex assays is required; familiarity with Biacore, Gyros and ForteBio is helpful. Experience with automated sample management systems is also extremely desirable. Other responsibilities include reporting study sample results to internal clients following the departmental policies and procedures and participating in troubleshooting assays whenever necessary. Contributions to the preparation and presentation of scientific material at internal meetings, as will publication of results as part of project participation. Ensures compliance with and maintains required training in the client and departmental SOPs, safety and other guidelines, and with applicable regulations. Ensures that notebooks and other documentations are up to date as per departmental SOPs. PPDFSP LI-SW1 Job Qualification Education and
Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10
years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
Experience in biological sample handling. Working understanding of manual methods and immunoassay technologies such as ELISA, ECL (MSD), ForteBio & Gyros. Ability to write in a concise fashion in order to record all pertinent data in research notebook. Knowledge of GLPs, 21 CFR Part 11, Bioanalytical Guidances (FDA, EMA), and departmental SOPs. A reasonable level of understanding of the immune system, antibody assays, and experience with clinical analysis is extremely desirable. Experience with automated sample management & assay systems also is desirable. Proficiency on technical operating systems Effective written and oral communication skills as well as presentation skills Knowledge and application of industry best practices not yet represented by global regulatory requirements Full theoretical and hands-on understanding and knowledge of general chemistry and separation science Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently review and understand project proposals/plans Proven ability in technical writing skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to independently optimize analytical methods Time management and project management skills
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10
years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
Experience in biological sample handling. Working understanding of manual methods and immunoassay technologies such as ELISA, ECL (MSD), ForteBio & Gyros. Ability to write in a concise fashion in order to record all pertinent data in research notebook. Knowledge of GLPs, 21 CFR Part 11, Bioanalytical Guidances (FDA, EMA), and departmental SOPs. A reasonable level of understanding of the immune system, antibody assays, and experience with clinical analysis is extremely desirable. Experience with automated sample management & assay systems also is desirable. Proficiency on technical operating systems Effective written and oral communication skills as well as presentation skills Knowledge and application of industry best practices not yet represented by global regulatory requirements Full theoretical and hands-on understanding and knowledge of general chemistry and separation science Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance Ability to independently review and understand project proposals/plans Proven ability in technical writing skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to independently optimize analytical methods Time management and project management skills
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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