Address
Form of workScientist 3
Location: South San Francisco, CA
Duration: 12 months
Description:
Department : Bio Analytical Sciences Operations (Client Ops)
Position : SE6-Scientist 3 Technical Oversight of Outsourced Methods (Ligand Binding Assays)
Job Description:
Bio Analytical Sciences Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies through global collaboration and robust CRO portfolio management.
Our team brings technical and operational expertise along with passion and drive to make a difference for patients.
The Scientist 3 will support the development portfolio by providing technical oversight of clinical and non-clinical bioanalytical methods including validation and lifecycle management of Ligand Binding Assays supporting pharmacokinetic, toxicokinetic, pharmacodynamic, and biomarker analyses outsourced to Contract Research Organizations (CRO).
The Scientist 3 will also review bioanalytical clinical and non-clinical method performance data generated at the CROs.
The Scientist 3 will support the Client portfolio by :
Serving as the front-line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (Ligand Binding Assays and new technologies) and any technical questions that arise around assay performance or lifecycle management during the course of clinical, non-clinical study assay performance.
Providing technical oversight of outsourced methods (Ligand Binding and new technologies), ensuring qualified/validated state for optimal assay quality:
Technical review of assay data from development, feasibility, qualification/validation, assay performance from clinical/non-clinical sample analysis.
Technical review plans (qualification/validation/sample analysis), reports (qualification/validation/sample analysis)
Technical support during assay troubleshooting and lifecycle management
Proprietary Critical Reagents (Reference standards, MAbs, ligands): forecasting, requesting new material, shipping, re-test date extension.
Supplemental validations to support additional matrices, disease states, co-medications, critical reagent incorporation, Coordinate assay transfers to multiple CROs and subsequent Technical support of cross validation experiments between CROs.
Generate internal technical reports: validation history, cross validation, or memorandum
Share with internal key stakeholders assay data (transfer, feasibility, qualification, validation, troubleshooting, assay performance) and documents (methods, plans, reports, memorandum).
May Lead technical teleconferences with CROs and attend internal bioanalytical working group meetings.
This individual will work in a fast-paced and highly collaborative team based environment.
She will be asked to present at bioanalytical working groups or all staff meetings and to prepare poster presentations.
She may train others on group responsibilities and systems.
She may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes.
Qualifications :
Bachelors or Masters degree in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 3-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO). Familiarity with bioanalytical method GxP compliance is required.
The Scientist 2 or 3 may have a technical background in developing, validating, implementing, maintaining, and troubleshooting quantitative assays as well as have demonstrated problem solving abilities of bioanalytical methods in: LC-MS
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.
Location: South San Francisco, CA
Duration: 12 months
Description:
Department : Bio Analytical Sciences Operations (Client Ops)
Position : SE6-Scientist 3 Technical Oversight of Outsourced Methods (Ligand Binding Assays)
Job Description:
Bio Analytical Sciences Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies through global collaboration and robust CRO portfolio management.
Our team brings technical and operational expertise along with passion and drive to make a difference for patients.
The Scientist 3 will support the development portfolio by providing technical oversight of clinical and non-clinical bioanalytical methods including validation and lifecycle management of Ligand Binding Assays supporting pharmacokinetic, toxicokinetic, pharmacodynamic, and biomarker analyses outsourced to Contract Research Organizations (CRO).
The Scientist 3 will also review bioanalytical clinical and non-clinical method performance data generated at the CROs.
The Scientist 3 will support the Client portfolio by :
Serving as the front-line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (Ligand Binding Assays and new technologies) and any technical questions that arise around assay performance or lifecycle management during the course of clinical, non-clinical study assay performance.
Providing technical oversight of outsourced methods (Ligand Binding and new technologies), ensuring qualified/validated state for optimal assay quality:
Technical review of assay data from development, feasibility, qualification/validation, assay performance from clinical/non-clinical sample analysis.
Technical review plans (qualification/validation/sample analysis), reports (qualification/validation/sample analysis)
Technical support during assay troubleshooting and lifecycle management
Proprietary Critical Reagents (Reference standards, MAbs, ligands): forecasting, requesting new material, shipping, re-test date extension.
Supplemental validations to support additional matrices, disease states, co-medications, critical reagent incorporation, Coordinate assay transfers to multiple CROs and subsequent Technical support of cross validation experiments between CROs.
Generate internal technical reports: validation history, cross validation, or memorandum
Share with internal key stakeholders assay data (transfer, feasibility, qualification, validation, troubleshooting, assay performance) and documents (methods, plans, reports, memorandum).
May Lead technical teleconferences with CROs and attend internal bioanalytical working group meetings.
This individual will work in a fast-paced and highly collaborative team based environment.
She will be asked to present at bioanalytical working groups or all staff meetings and to prepare poster presentations.
She may train others on group responsibilities and systems.
She may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes.
Qualifications :
Bachelors or Masters degree in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 3-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO). Familiarity with bioanalytical method GxP compliance is required.
The Scientist 2 or 3 may have a technical background in developing, validating, implementing, maintaining, and troubleshooting quantitative assays as well as have demonstrated problem solving abilities of bioanalytical methods in: LC-MS
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.
