Senior Scientist - ELISA and Bioanalytical Immunoassays

Pharmaceutical Product Development (PPD)

NJ-Princeton-FSP Lawrenceville NJ


Submission for the position: Senior Scientist - ELISA and Bioanalytical Immunoassays - (Job Number: 182496)

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.

The primary responsibility of this position is to support the validation and implementation of bioanalytical immunoassays (LBA) for the analysis of nonclinical and clinical biomarker samples in a discovery and regulated (GLP and clinical), with cross-training opportunities supporting pharmacokinetic and immunogenicity sample validation/analysis utilizing various technologies (LBA, LC-MS/MS). The individual will report study sample results to clients following department policies and procedures; will troubleshoot assays when problems arise; and will communicate laboratory results.

Scope of Work:

• Validates and implements immunoassays for the analysis of samples in a GLP or GLP-like environment with some level of guidance using validated and qualified methods. Reports study sample results.

• Contributes to validation and study reports.

• Troubleshoots ordinary assay issues.

• Ensures compliance with and maintains required training in clientand departmental GLP, SOP, safety and other departmental guidelines.

• Ensures that notebooks and other documentations are up-to-date as per departmental guidelines.

*LI-SW1

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.

The primary responsibility of this position is to support the validation and implementation of bioanalytical immunoassays (LBA) for the analysis of nonclinical and clinical biomarker samples in a discovery and regulated (GLP and clinical), with cross-training opportunities supporting pharmacokinetic and immunogenicity sample validation/analysis utilizing various technologies (LBA, LC-MS/MS). The individual will report study sample results to clients following department policies and procedures; will troubleshoot assays when problems arise; and will communicate laboratory results.

Scope of Work:

• Validates and implements immunoassays for the analysis of samples in a GLP or GLP-like environment with some level of guidance using validated and qualified methods. Reports study sample results.

• Contributes to validation and study reports.

• Troubleshoots ordinary assay issues.

• Ensures compliance with and maintains required training in clientand departmental GLP, SOP, safety and other departmental guidelines.

• Ensures that notebooks and other documentations are up-to-date as per departmental guidelines.

*LI-SW1

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 2 years).

In somecases,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: Good understanding of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc.). Goodbasic analytical lab operational skills (pipettes, balances, computer skills, etc.). Ability to work in a methodical and organized fashion; read and follow method or research protocols; and write in a concise and accurate manner in order to record all pertinent data in a research notebook. Demonstrate scientific/technical proficiency. Strong theoretical understanding of immunoassays: ELISA, ECL, Gyros, Western Blot, BIACore, immunogenicity assays, cell-based assays. Working knowledge and experience in extraction techniques (PPT, LLE, SPE, immunocapture, etc.) and LC-MS/MS instrumentation. Some experience in LIMS (e.g. Watson) for quantitation, data handling, and archival. Working knowledge of GLPs, 21 CFR Part 11, FDA Bioanalytical Guidance documents. Basic understanding of instrumental and protocol troubleshooting.

Proficient in Microsoft Excel and Word

Proven ability in technical writing skills

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills

Ability to work in a collaborative work environment with a team

Working Environment: 

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.   

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

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 2 years).

In somecases,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: Good understanding of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc.). Goodbasic analytical lab operational skills (pipettes, balances, computer skills, etc.). Ability to work in a methodical and organized fashion; read and follow method or research protocols; and write in a concise and accurate manner in order to record all pertinent data in a research notebook. Demonstrate scientific/technical proficiency. Strong theoretical understanding of immunoassays: ELISA, ECL, Gyros, Western Blot, BIACore, immunogenicity assays, cell-based assays. Working knowledge and experience in extraction techniques (PPT, LLE, SPE, immunocapture, etc.) and LC-MS/MS instrumentation. Some experience in LIMS (e.g. Watson) for quantitation, data handling, and archival. Working knowledge of GLPs, 21 CFR Part 11, FDA Bioanalytical Guidance documents. Basic understanding of instrumental and protocol troubleshooting.

Proficient in Microsoft Excel and Word

Proven ability in technical writing skills

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills

Ability to work in a collaborative work environment with a team

Working Environment: 

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.   

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.    

Submission for the position: Senior Scientist - ELISA and Bioanalytical Immunoassays - (Job Number: 182496)


2021-02-23 00:00:00


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