Associate Director Bioanalytical Development
We seek an Associate Director to manage the operations and scientific oversight of contracted clinical and nonclinical GLP, GMP, and GCP bioanalytics. The incumbent will contribute to Xencor's engineered protein therapeutic product development pipeline by providing scientific leadership in the development, transfer, and troubleshooting of immunoassays and bioassays (including potency, pharmacokinetic, biomarkers, identity, and others as needed).
Job duties include:
Technical Supplier Relationship and Performance Management (SRM/SPM)
Technical oversight of GXP bioanalytical method development, transfer, qualification, validation and investigation
On-site technical trainer and monitor of bioanalytical contract laboratories; liaison to Quality Assurance
Trending of bioanalytical method performance and specifications
Bioanalytical method results data analysis, review, interpretation, investigation, and reporting
Contract and budget management; functional liaison to Finance
Bioanalytical study management; functional liaison to Clinical Operations
oEnsure accuracy and technical integrity of study plans and reports
oEnsure critical reagent supply and quality
oTimeline and resource management
Operational excellence/business process continuous improvement
Maintain current knowledge of the field and area(s) of scientific expertise and developmentBachelor of Science in biology, chemistry or similar field
Masters degree and/or PhD in science, biotechnology, and/or business
Minimum of 5 years of industry experience in GXP laboratory developing, validating and performing a variety of bioanalytical methods (wet lab)
Minimum of 3 years of industry experience as GLP Principal Investigator or GXP Contributing Scientist responsible for data review, approval and reporting
Familiarity with regulations, guidances and white papers on GXP bioanalytical method development, validation, and sample analysis (US and EU).
Experience in client or supplier relationship and performance management
Experience transferring bioanalytical methods between laboratories.
Expertise in ligand binding assays, immunoassays, and cell-based assays across multiple platforms to generate data for pharmacokinetics, immunogenicity, biomarkers and/or relative potency.
High competence in the use of software for experimental design of experiments (DOE) and data analysis (e.g. JMP, GraphPad Prism, SoftMax Pro; Microsoft Office tools)
Experience in GxP regulations for laboratory practices and compliance with regulatory agencies (US and EU)
Excellent communication, matrix management, issue management, negotiation and alliance/partner/customer management skills
Attention to detail, critical thinking, and ability to prioritize and solve problems of varying complexity
This job involves periodic travel to monitor, train, and support external labs
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at EOEEstimated Salary: $20 to $28 per hour based on qualifications.
Job duties include:
Technical Supplier Relationship and Performance Management (SRM/SPM)
Technical oversight of GXP bioanalytical method development, transfer, qualification, validation and investigation
On-site technical trainer and monitor of bioanalytical contract laboratories; liaison to Quality Assurance
Trending of bioanalytical method performance and specifications
Bioanalytical method results data analysis, review, interpretation, investigation, and reporting
Contract and budget management; functional liaison to Finance
Bioanalytical study management; functional liaison to Clinical Operations
oEnsure accuracy and technical integrity of study plans and reports
oEnsure critical reagent supply and quality
oTimeline and resource management
Operational excellence/business process continuous improvement
Maintain current knowledge of the field and area(s) of scientific expertise and developmentBachelor of Science in biology, chemistry or similar field
Masters degree and/or PhD in science, biotechnology, and/or business
Minimum of 5 years of industry experience in GXP laboratory developing, validating and performing a variety of bioanalytical methods (wet lab)
Minimum of 3 years of industry experience as GLP Principal Investigator or GXP Contributing Scientist responsible for data review, approval and reporting
Familiarity with regulations, guidances and white papers on GXP bioanalytical method development, validation, and sample analysis (US and EU).
Experience in client or supplier relationship and performance management
Experience transferring bioanalytical methods between laboratories.
Expertise in ligand binding assays, immunoassays, and cell-based assays across multiple platforms to generate data for pharmacokinetics, immunogenicity, biomarkers and/or relative potency.
High competence in the use of software for experimental design of experiments (DOE) and data analysis (e.g. JMP, GraphPad Prism, SoftMax Pro; Microsoft Office tools)
Experience in GxP regulations for laboratory practices and compliance with regulatory agencies (US and EU)
Excellent communication, matrix management, issue management, negotiation and alliance/partner/customer management skills
Attention to detail, critical thinking, and ability to prioritize and solve problems of varying complexity
This job involves periodic travel to monitor, train, and support external labs
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at EOEEstimated Salary: $20 to $28 per hour based on qualifications.
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