Principal Investigator, Bioanalysis
Posted on Sep 26, 2024 by Incyte Corporation
Wilmington, DE
Education
Immediate Start
Annual Salary
Full-Time
Overview:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Bioanalysis group is seeking a highly motivated and large molecule-focused bioanalytical scientist to provide strategic support to the discovery, nonclinical and clinical development of biologic drugs. The selected individual will be an integral project team member representing Bioanalysis on biologics research projects to ensure delivery of high quality data within project timelines to support regulatory filings.
Essential Functions of the Job (Key responsibilities)
Conduct bioanalytical method development and validation and sample analysis to support Incyte discovery and development programs.
Manage resources and prioritize studies in close communications with different groups including bioanalytical scientists, toxicology, pharmacology, DMPK, clinical PK, clinical operations, and clinical scientist. Perform/oversee bioanalytical method development and validation for PK and Immunogenicity assays in a discovery mode or in a regulated environment.
Provide sample analysis in support of clinical, toxicology, DMPK, pharmacology, and other studies.
Provide data to pharmacokineticists, toxicokineticists, DMPK, line management, and project teams as needed.
Compliance with GLP and GCP regulations, follow company policies and SOPs, as applicable.
Closely working with Quality Assurance to ensure data quality and compliance, as applicable.
Review bioanalytical data and bioanalytical reports.
Contribute to clinical study reports and IND/NDA submission documents, as required.
Troubleshoot assay and instrumentation problems.
Train and assist junior scientists in the group on large molecule PK and Immunogenicity method optimization and troubleshooting.
Present study results to working group as needed.
Act as a bioanalytical phase Principle Investigator, if needed.
Manage bioanalytical studies at CROs, if required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS/PhD degree or equivalent in Life Sciences or related discipline
At least 10 years (BS) /7 years (MS)/5 year (PhD) related experience in pharmaceutical companies or CROs
Knowledge of DMPK is required.
Strong hands-on experience in large molecule PK assays and Immunogenicity assays, including Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb assays).
A broad knowledge of drug discovery and development, especially DMPK knowledge, is desirable.
Must have GLP and GCP knowledge and experience working in a regulated environment, if assigned tasks in regulated bioanalysis.
Excellent oral and written communication skills are essential along with strong organizational skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact (url removed) if you have any questions or concerns or would like to exercise your rights.
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Bioanalysis group is seeking a highly motivated and large molecule-focused bioanalytical scientist to provide strategic support to the discovery, nonclinical and clinical development of biologic drugs. The selected individual will be an integral project team member representing Bioanalysis on biologics research projects to ensure delivery of high quality data within project timelines to support regulatory filings.
Essential Functions of the Job (Key responsibilities)
Conduct bioanalytical method development and validation and sample analysis to support Incyte discovery and development programs.
Manage resources and prioritize studies in close communications with different groups including bioanalytical scientists, toxicology, pharmacology, DMPK, clinical PK, clinical operations, and clinical scientist. Perform/oversee bioanalytical method development and validation for PK and Immunogenicity assays in a discovery mode or in a regulated environment.
Provide sample analysis in support of clinical, toxicology, DMPK, pharmacology, and other studies.
Provide data to pharmacokineticists, toxicokineticists, DMPK, line management, and project teams as needed.
Compliance with GLP and GCP regulations, follow company policies and SOPs, as applicable.
Closely working with Quality Assurance to ensure data quality and compliance, as applicable.
Review bioanalytical data and bioanalytical reports.
Contribute to clinical study reports and IND/NDA submission documents, as required.
Troubleshoot assay and instrumentation problems.
Train and assist junior scientists in the group on large molecule PK and Immunogenicity method optimization and troubleshooting.
Present study results to working group as needed.
Act as a bioanalytical phase Principle Investigator, if needed.
Manage bioanalytical studies at CROs, if required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS/PhD degree or equivalent in Life Sciences or related discipline
At least 10 years (BS) /7 years (MS)/5 year (PhD) related experience in pharmaceutical companies or CROs
Knowledge of DMPK is required.
Strong hands-on experience in large molecule PK assays and Immunogenicity assays, including Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb assays).
A broad knowledge of drug discovery and development, especially DMPK knowledge, is desirable.
Must have GLP and GCP knowledge and experience working in a regulated environment, if assigned tasks in regulated bioanalysis.
Excellent oral and written communication skills are essential along with strong organizational skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact (url removed) if you have any questions or concerns or would like to exercise your rights.
Reference: 202542218
https://jobs.careeraddict.com/post/95603426
Principal Investigator, Bioanalysis
Posted on Sep 26, 2024 by Incyte Corporation
Wilmington, DE
Education
Immediate Start
Annual Salary
Full-Time
Overview:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Bioanalysis group is seeking a highly motivated and large molecule-focused bioanalytical scientist to provide strategic support to the discovery, nonclinical and clinical development of biologic drugs. The selected individual will be an integral project team member representing Bioanalysis on biologics research projects to ensure delivery of high quality data within project timelines to support regulatory filings.
Essential Functions of the Job (Key responsibilities)
Conduct bioanalytical method development and validation and sample analysis to support Incyte discovery and development programs.
Manage resources and prioritize studies in close communications with different groups including bioanalytical scientists, toxicology, pharmacology, DMPK, clinical PK, clinical operations, and clinical scientist. Perform/oversee bioanalytical method development and validation for PK and Immunogenicity assays in a discovery mode or in a regulated environment.
Provide sample analysis in support of clinical, toxicology, DMPK, pharmacology, and other studies.
Provide data to pharmacokineticists, toxicokineticists, DMPK, line management, and project teams as needed.
Compliance with GLP and GCP regulations, follow company policies and SOPs, as applicable.
Closely working with Quality Assurance to ensure data quality and compliance, as applicable.
Review bioanalytical data and bioanalytical reports.
Contribute to clinical study reports and IND/NDA submission documents, as required.
Troubleshoot assay and instrumentation problems.
Train and assist junior scientists in the group on large molecule PK and Immunogenicity method optimization and troubleshooting.
Present study results to working group as needed.
Act as a bioanalytical phase Principle Investigator, if needed.
Manage bioanalytical studies at CROs, if required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS/PhD degree or equivalent in Life Sciences or related discipline
At least 10 years (BS) /7 years (MS)/5 year (PhD) related experience in pharmaceutical companies or CROs
Knowledge of DMPK is required.
Strong hands-on experience in large molecule PK assays and Immunogenicity assays, including Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb assays).
A broad knowledge of drug discovery and development, especially DMPK knowledge, is desirable.
Must have GLP and GCP knowledge and experience working in a regulated environment, if assigned tasks in regulated bioanalysis.
Excellent oral and written communication skills are essential along with strong organizational skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact (url removed) if you have any questions or concerns or would like to exercise your rights.
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Bioanalysis group is seeking a highly motivated and large molecule-focused bioanalytical scientist to provide strategic support to the discovery, nonclinical and clinical development of biologic drugs. The selected individual will be an integral project team member representing Bioanalysis on biologics research projects to ensure delivery of high quality data within project timelines to support regulatory filings.
Essential Functions of the Job (Key responsibilities)
Conduct bioanalytical method development and validation and sample analysis to support Incyte discovery and development programs.
Manage resources and prioritize studies in close communications with different groups including bioanalytical scientists, toxicology, pharmacology, DMPK, clinical PK, clinical operations, and clinical scientist. Perform/oversee bioanalytical method development and validation for PK and Immunogenicity assays in a discovery mode or in a regulated environment.
Provide sample analysis in support of clinical, toxicology, DMPK, pharmacology, and other studies.
Provide data to pharmacokineticists, toxicokineticists, DMPK, line management, and project teams as needed.
Compliance with GLP and GCP regulations, follow company policies and SOPs, as applicable.
Closely working with Quality Assurance to ensure data quality and compliance, as applicable.
Review bioanalytical data and bioanalytical reports.
Contribute to clinical study reports and IND/NDA submission documents, as required.
Troubleshoot assay and instrumentation problems.
Train and assist junior scientists in the group on large molecule PK and Immunogenicity method optimization and troubleshooting.
Present study results to working group as needed.
Act as a bioanalytical phase Principle Investigator, if needed.
Manage bioanalytical studies at CROs, if required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS/PhD degree or equivalent in Life Sciences or related discipline
At least 10 years (BS) /7 years (MS)/5 year (PhD) related experience in pharmaceutical companies or CROs
Knowledge of DMPK is required.
Strong hands-on experience in large molecule PK assays and Immunogenicity assays, including Anti-drug Antibody (ADA) and Neutralizing Antibody (NAb assays).
A broad knowledge of drug discovery and development, especially DMPK knowledge, is desirable.
Must have GLP and GCP knowledge and experience working in a regulated environment, if assigned tasks in regulated bioanalysis.
Excellent oral and written communication skills are essential along with strong organizational skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
Please contact (url removed) if you have any questions or concerns or would like to exercise your rights.
Reference: 202542218
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