Merck Sharp & Dohme
Senior Scientist, Bioanalytical Regulated Immunogenicity and Molecular
Merck Sharp & Dohme, Ambler, Alaska, us, 99786
Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We are seeking a highly motivated Senior Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Bioanalytical Regulated Immunogenicity and Molecular. Our team is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis, and visualization, and automated liquid handling. The successful candidate will design, develop, and support bioanalytical vaccine immunogenicity assays to support regulated preclinical and clinical vaccine development. The individual will be responsible to contribute with limited supervision to all hands-on laboratory aspects of bioanalytical assay development, qualification/validation, technology transfer, and/or troubleshooting. The candidate will understand and leverage automation technologies across assay development, support, and data analysis. A strong, solution-focused scientific background is critical. Preferably, the successful candidate should have a proven track record for developing assays capable to meet regulatory expectations for validation and line of sight for life-cycle maintenance. The candidate should be current on state-of-the-art technologies and is expected to champion evaluation of new technologies and optimize processes to increase throughput and reduce turn-around times. Providing expert technical representation on multidisciplinary teams will be expected.
Responsibilities
Leverage a strong scientific background to design, develop, and support ligand binding assays such as Luminex, Mesoscale, ELISA and/or cell-based functional immunogenicity assays.
Responsible for the execution of method development, qualification/validation, troubleshooting and/or pre-clinical/clinical sample analysis as needed.
Operation, understanding, and utilization of automated equipment.
Contribute to the assessment and implementation of new analytical technologies with a focus on problem-solving.
Understand and adhere to regulated frameworks and guidances in collaboration with team leads and Quality Assurance.
Serve as an internal subject matter expert on scientific background and laboratory aspects of bioanalytical development.
Holistically, systematically, and efficiently analyze data, determine trends, and communicate to teams and leadership.
Strong understanding of systematic scientific concepts and interest in associated laboratory experimentation.
Comply with applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address QA findings and observations.
Adherence to basic safety procedures in a BSL2 laboratory.
Qualifications:
Minimum education required:
PhD in Biological Sciences or related area with 0+ years (with expected completion no later than December 2024), or a MS degree with 4+ years, or a BS degree with 7+ years.
Required experience and skills:
Knowledge and expertise in assay qualification/validation and troubleshooting of ligand binding immunogenicity assays based on technologies such as Luminex, Mesoscale, or ELISA, and/or experience with in vitro cell-based functional immunogenicity assays such as virus neutralization assays or plaque assays.
Critical scientific thinking and systematic trouble-shooting skills.
Good verbal and written communication skills to explain and communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams.
Ability to follow procedures and regulations, and thorough, detail-oriented documentation.
Familiarity with liquid handlers and other automation platforms such as Biomek, Hamilton, or Tecan liquid handlers for sample preparation and assay process is preferred.
Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) and regulations as pertain to bioanalysis are strongly desired.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Shift:
1st - Day
Hazardous Material(s):
BSL-2
Job Posting End Date:
10/21/2024
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Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We are seeking a highly motivated Senior Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Bioanalytical Regulated Immunogenicity and Molecular. Our team is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis, and visualization, and automated liquid handling. The successful candidate will design, develop, and support bioanalytical vaccine immunogenicity assays to support regulated preclinical and clinical vaccine development. The individual will be responsible to contribute with limited supervision to all hands-on laboratory aspects of bioanalytical assay development, qualification/validation, technology transfer, and/or troubleshooting. The candidate will understand and leverage automation technologies across assay development, support, and data analysis. A strong, solution-focused scientific background is critical. Preferably, the successful candidate should have a proven track record for developing assays capable to meet regulatory expectations for validation and line of sight for life-cycle maintenance. The candidate should be current on state-of-the-art technologies and is expected to champion evaluation of new technologies and optimize processes to increase throughput and reduce turn-around times. Providing expert technical representation on multidisciplinary teams will be expected.
Responsibilities
Leverage a strong scientific background to design, develop, and support ligand binding assays such as Luminex, Mesoscale, ELISA and/or cell-based functional immunogenicity assays.
Responsible for the execution of method development, qualification/validation, troubleshooting and/or pre-clinical/clinical sample analysis as needed.
Operation, understanding, and utilization of automated equipment.
Contribute to the assessment and implementation of new analytical technologies with a focus on problem-solving.
Understand and adhere to regulated frameworks and guidances in collaboration with team leads and Quality Assurance.
Serve as an internal subject matter expert on scientific background and laboratory aspects of bioanalytical development.
Holistically, systematically, and efficiently analyze data, determine trends, and communicate to teams and leadership.
Strong understanding of systematic scientific concepts and interest in associated laboratory experimentation.
Comply with applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address QA findings and observations.
Adherence to basic safety procedures in a BSL2 laboratory.
Qualifications:
Minimum education required:
PhD in Biological Sciences or related area with 0+ years (with expected completion no later than December 2024), or a MS degree with 4+ years, or a BS degree with 7+ years.
Required experience and skills:
Knowledge and expertise in assay qualification/validation and troubleshooting of ligand binding immunogenicity assays based on technologies such as Luminex, Mesoscale, or ELISA, and/or experience with in vitro cell-based functional immunogenicity assays such as virus neutralization assays or plaque assays.
Critical scientific thinking and systematic trouble-shooting skills.
Good verbal and written communication skills to explain and communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams.
Ability to follow procedures and regulations, and thorough, detail-oriented documentation.
Familiarity with liquid handlers and other automation platforms such as Biomek, Hamilton, or Tecan liquid handlers for sample preparation and assay process is preferred.
Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) and regulations as pertain to bioanalysis are strongly desired.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Shift:
1st - Day
Hazardous Material(s):
BSL-2
Job Posting End Date:
10/21/2024
#J-18808-Ljbffr