Principal Research Scientist I - QC Bioassay Lab Head
Posted on Sep 21, 2024 by AbbVie
South San Francisco, CA
Research
Immediate Start
Annual Salary
Full-Time
Job Description
We are seeking a Principal Research Scientist I - QC Bioassay Lab Head to join our Bioassay Development and QC team. The QC Bioassay Lab Head will support the development and evaluation of newly discovered oncology and immunology drugs and existing clinical candidates, including antibody therapeutics, antibody-drug conjugates (ADCs), multi-specific biologics, and other complex biologic modalities. This person will lead the ongoing establishment of a new QC Bioassay laboratory and then oversee and coordinate the GMP release and stability potency testing of biologics for early development programs. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. In this role you will have unique exposure to a significant breadth and depth of drug development experience, numerous cross-functional interactions, and opportunities to grow and develop in your career.
Responsibilities:
In this lab-based role, your major responsibilities will include:
Lead the ongoing efforts to establish a new QC Bioassay lab at the South San Francisco site, which will focus on QC target-binding potency assays (ELISA, TR-FRET, etc) and cell-based functional potency assays (cell-killing, reporter assays, effector function, etc).
Interact and collaborate across multiple sites, functions, and groups (such as QC, QA, Facilities, IT, external vendors, etc) to enable establishment of a new QC Bioassay lab.
Ensure all elements of the QC Bioassay Lab (plate readers, plate washers, software, reagents, cells, incubators, sample storage, environmental monitoring, etc) are organized, maintained, and in compliance.
Ensure equipment, instruments, and software are appropriately qualified/validated.
Work closely with Bioassay Development scientists to enable rapid and efficient establishment of novel, complex potency assays in QC, including method qualification, validation, documentation, and troubleshooting.
Plan, schedule, track, and document the QC activities of bioassay scientists for the release and stability testing of drug substance and drug product batches to provide key data for regulatory submissions.
Monitor and track metrics for the QC Bioassay Lab
Ensure QC activities are in conformance with AbbVie Quality System requirements and applicable regulatory and compendial requirements. Must be familiar with ICH and GMP Guidelines.
Collaborate with QC and QA counterparts to support resolution of deviations and investigations.
Provide audit support (prep, during and post audit commitments) and participate in CAPA activities.
Represent the QC Bioassay Lab in meetings and initiatives with QC labs at other AbbVie sites.
We are seeking a Principal Research Scientist I - QC Bioassay Lab Head to join our Bioassay Development and QC team. The QC Bioassay Lab Head will support the development and evaluation of newly discovered oncology and immunology drugs and existing clinical candidates, including antibody therapeutics, antibody-drug conjugates (ADCs), multi-specific biologics, and other complex biologic modalities. This person will lead the ongoing establishment of a new QC Bioassay laboratory and then oversee and coordinate the GMP release and stability potency testing of biologics for early development programs. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. In this role you will have unique exposure to a significant breadth and depth of drug development experience, numerous cross-functional interactions, and opportunities to grow and develop in your career.
Responsibilities:
In this lab-based role, your major responsibilities will include:
Lead the ongoing efforts to establish a new QC Bioassay lab at the South San Francisco site, which will focus on QC target-binding potency assays (ELISA, TR-FRET, etc) and cell-based functional potency assays (cell-killing, reporter assays, effector function, etc).
Interact and collaborate across multiple sites, functions, and groups (such as QC, QA, Facilities, IT, external vendors, etc) to enable establishment of a new QC Bioassay lab.
Ensure all elements of the QC Bioassay Lab (plate readers, plate washers, software, reagents, cells, incubators, sample storage, environmental monitoring, etc) are organized, maintained, and in compliance.
Ensure equipment, instruments, and software are appropriately qualified/validated.
Work closely with Bioassay Development scientists to enable rapid and efficient establishment of novel, complex potency assays in QC, including method qualification, validation, documentation, and troubleshooting.
Plan, schedule, track, and document the QC activities of bioassay scientists for the release and stability testing of drug substance and drug product batches to provide key data for regulatory submissions.
Monitor and track metrics for the QC Bioassay Lab
Ensure QC activities are in conformance with AbbVie Quality System requirements and applicable regulatory and compendial requirements. Must be familiar with ICH and GMP Guidelines.
Collaborate with QC and QA counterparts to support resolution of deviations and investigations.
Provide audit support (prep, during and post audit commitments) and participate in CAPA activities.
Represent the QC Bioassay Lab in meetings and initiatives with QC labs at other AbbVie sites.
Reference: 202108938
https://jobs.careeraddict.com/post/95491908
Principal Research Scientist I - QC Bioassay Lab Head
Posted on Sep 21, 2024 by AbbVie
South San Francisco, CA
Research
Immediate Start
Annual Salary
Full-Time
Job Description
We are seeking a Principal Research Scientist I - QC Bioassay Lab Head to join our Bioassay Development and QC team. The QC Bioassay Lab Head will support the development and evaluation of newly discovered oncology and immunology drugs and existing clinical candidates, including antibody therapeutics, antibody-drug conjugates (ADCs), multi-specific biologics, and other complex biologic modalities. This person will lead the ongoing establishment of a new QC Bioassay laboratory and then oversee and coordinate the GMP release and stability potency testing of biologics for early development programs. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. In this role you will have unique exposure to a significant breadth and depth of drug development experience, numerous cross-functional interactions, and opportunities to grow and develop in your career.
Responsibilities:
In this lab-based role, your major responsibilities will include:
Lead the ongoing efforts to establish a new QC Bioassay lab at the South San Francisco site, which will focus on QC target-binding potency assays (ELISA, TR-FRET, etc) and cell-based functional potency assays (cell-killing, reporter assays, effector function, etc).
Interact and collaborate across multiple sites, functions, and groups (such as QC, QA, Facilities, IT, external vendors, etc) to enable establishment of a new QC Bioassay lab.
Ensure all elements of the QC Bioassay Lab (plate readers, plate washers, software, reagents, cells, incubators, sample storage, environmental monitoring, etc) are organized, maintained, and in compliance.
Ensure equipment, instruments, and software are appropriately qualified/validated.
Work closely with Bioassay Development scientists to enable rapid and efficient establishment of novel, complex potency assays in QC, including method qualification, validation, documentation, and troubleshooting.
Plan, schedule, track, and document the QC activities of bioassay scientists for the release and stability testing of drug substance and drug product batches to provide key data for regulatory submissions.
Monitor and track metrics for the QC Bioassay Lab
Ensure QC activities are in conformance with AbbVie Quality System requirements and applicable regulatory and compendial requirements. Must be familiar with ICH and GMP Guidelines.
Collaborate with QC and QA counterparts to support resolution of deviations and investigations.
Provide audit support (prep, during and post audit commitments) and participate in CAPA activities.
Represent the QC Bioassay Lab in meetings and initiatives with QC labs at other AbbVie sites.
We are seeking a Principal Research Scientist I - QC Bioassay Lab Head to join our Bioassay Development and QC team. The QC Bioassay Lab Head will support the development and evaluation of newly discovered oncology and immunology drugs and existing clinical candidates, including antibody therapeutics, antibody-drug conjugates (ADCs), multi-specific biologics, and other complex biologic modalities. This person will lead the ongoing establishment of a new QC Bioassay laboratory and then oversee and coordinate the GMP release and stability potency testing of biologics for early development programs. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. In this role you will have unique exposure to a significant breadth and depth of drug development experience, numerous cross-functional interactions, and opportunities to grow and develop in your career.
Responsibilities:
In this lab-based role, your major responsibilities will include:
Lead the ongoing efforts to establish a new QC Bioassay lab at the South San Francisco site, which will focus on QC target-binding potency assays (ELISA, TR-FRET, etc) and cell-based functional potency assays (cell-killing, reporter assays, effector function, etc).
Interact and collaborate across multiple sites, functions, and groups (such as QC, QA, Facilities, IT, external vendors, etc) to enable establishment of a new QC Bioassay lab.
Ensure all elements of the QC Bioassay Lab (plate readers, plate washers, software, reagents, cells, incubators, sample storage, environmental monitoring, etc) are organized, maintained, and in compliance.
Ensure equipment, instruments, and software are appropriately qualified/validated.
Work closely with Bioassay Development scientists to enable rapid and efficient establishment of novel, complex potency assays in QC, including method qualification, validation, documentation, and troubleshooting.
Plan, schedule, track, and document the QC activities of bioassay scientists for the release and stability testing of drug substance and drug product batches to provide key data for regulatory submissions.
Monitor and track metrics for the QC Bioassay Lab
Ensure QC activities are in conformance with AbbVie Quality System requirements and applicable regulatory and compendial requirements. Must be familiar with ICH and GMP Guidelines.
Collaborate with QC and QA counterparts to support resolution of deviations and investigations.
Provide audit support (prep, during and post audit commitments) and participate in CAPA activities.
Represent the QC Bioassay Lab in meetings and initiatives with QC labs at other AbbVie sites.
Reference: 202108938
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