Associate Director Bio-analytical Development - Monrovia, CA | Biospace
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Associate Director Bio-analytical Development

Xencor

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Location:
Monrovia, CA
Posted Date:
6/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Associate, Bioanalytical, Development, Director,

Job Description


Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego.  We have a very deep drug development pipeline including three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for an Associate Director Bioanalytical Development to join our team.  We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life.  In addition to generating a pipeline of novel drug candidates, with ten in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations  with leading biopharmaceutical companies including Novartis, Amgen,  Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.  

Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.

We seek an Associate Director Bioanalytical Development to

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
    o   Ensure accuracy and technical integrity of study plans and reports
    o   Ensure critical reagent supply and quality
    o   Timeline and resource management
•   Operational excellence/business process continuous improvement
•   Maintain current knowledge of the field and area(s) of scientific expertise and development

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Requirements


•   Bachelor 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 www.xencor.com   EOE