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Senior Scientist - TK , Immunoassay , ELISA , GLP

Pharmaceutical Product Development (PPD)

NJ-Princeton-FSP Lawrenceville NJ

Submission for the position: Senior Scientist - TK , Immunoassay , ELISA , GLP - (Job Number: 171799)PPD is a leading global contract research organization. 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. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

The primary responsibility of this role is to support the development, validation, and implementation of bioanalytical pharmacokinetic and immunogenicity immunoassays (e.g. ligand binding assays) for the analysis of nonclinical and clinical samples in a regulated environment. The individual will report study sample results following department policies and procedures; will troubleshoot assays when problems arise; and will communicate laboratory results.

Responsibilities:

Develops, validates, and implements immunoassays for the analysis of nonclinical and clinical pharmacokinetic, toxicokinetic, or immunogenicity samples in a GLP or GLP-like environment with some level of guidance

Processes bioanalytical study samples using validated methods. Reports study sample results.

Contributes to validation and bioanalytical study reports, BAS sections to the TK and clinical study reports.

Troubleshoots ordinary assay issues

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

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

Achieves objectives in a manner consistent with the Client Behaviors.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPDFSP

PPD is a leading global contract research organization. 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. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

The primary responsibility of this role is to support the development, validation, and implementation of bioanalytical pharmacokinetic and immunogenicity immunoassays (e.g. ligand binding assays) for the analysis of nonclinical and clinical samples in a regulated environment. The individual will report study sample results following department policies and procedures; will troubleshoot assays when problems arise; and will communicate laboratory results.

Responsibilities:

Develops, validates, and implements immunoassays for the analysis of nonclinical and clinical pharmacokinetic, toxicokinetic, or immunogenicity samples in a GLP or GLP-like environment with some level of guidance

Processes bioanalytical study samples using validated methods. Reports study sample results.

Contributes to validation and bioanalytical study reports, BAS sections to the TK and clinical study reports.

Troubleshoots ordinary assay issues

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

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

Achieves objectives in a manner consistent with the Client Behaviors.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPDFSP

Qualifications

Education and Experience: Bachelor's degree or equivalent and relevant formal academic/ vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years)

Knowledge, Skills and Abilities: Good understanding of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc).

At least 2 years of ELISA experience in a GLP or GMP regulated lab is required.

Good basic analytical lab operational skills (pipettors, balances, computer skills, etc).

Ability to work in a methodical and organized fashion.Ability to read and follow method or research protocols.

Ability to write in a concise fashion in order to record all pertinent data in lab notebook.

Demonstrate scientific/technical proficiency.Good theoretical understanding of immunoassays: ELISA, ECL, Gyros, BIACore, immunogenicity assays, cell based assaysGood verbal communication.

Some experience in LIMS (e.g. Watson) for quantitation, data handling, and archival is preferred.

Knowledge of GLPs, 21 CFR Part 11, FDA Bioanalytical Guidance documentsBasic understanding of instrumental and protocol troubleshootingAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilities

PPD values the health and wellbeing 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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendance

Qualifications

Education and Experience: Bachelor's degree or equivalent and relevant formal academic/ vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years)

Knowledge, Skills and Abilities: Good understanding of basic analytical concepts (concentration units, pH, calibration curves, QCs, compliance, etc).

At least 2 years of ELISA experience in a GLP or GMP regulated lab is required.

Good basic analytical lab operational skills (pipettors, balances, computer skills, etc).

Ability to work in a methodical and organized fashion.Ability to read and follow method or research protocols.

Ability to write in a concise fashion in order to record all pertinent data in lab notebook.

Demonstrate scientific/technical proficiency.Good theoretical understanding of immunoassays: ELISA, ECL, Gyros, BIACore, immunogenicity assays, cell based assaysGood verbal communication.

Some experience in LIMS (e.g. Watson) for quantitation, data handling, and archival is preferred.

Knowledge of GLPs, 21 CFR Part 11, FDA Bioanalytical Guidance documentsBasic understanding of instrumental and protocol troubleshootingAbility to work in a collaborative work environment with a teamProven problem solving and troubleshooting abilities

PPD values the health and wellbeing 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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesRegular and consistent attendanceSubmission for the position: Senior Scientist - TK , Immunoassay , ELISA , GLP - (Job Number: 171799)

Job posted: 2020-06-25

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