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Associate Director, Bioanalysis

Irving, TX, USA | Reata Pharmaceuticals, Inc.

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    7-10 years
Job Description:
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The Associate Director, Bioanalysis will provide hands-on leadership over the bioanalytical chemistry laboratory, including analytical assay development for novel small molecule drugs and potential drug metabolites.This experienced professional will support non-GLP and GLP/clinical bioanalysis, either in-house or in collaboration with external laboratories; he/she will also oversee the development and execution of relevant in vitro DMPK assays (e.g., microsomal stability). 


RESPONSIBILITIES:


Manage the in-house bioanalytical group to develop accurate and reliable methods for the detection of parent drug and metabolites in biological samples with HPLC-MS/MS instrumentation in support of nonclinical studies

Assist in the planning and management of resources and budget for bioanalytical lab

Ensure compliance with applicable requirements and regulatory expectations (e.g., GLP/GCP)

Review in-house data and ensure appropriate interpretation and documentation

Lead and participate in metabolic screening using in vitro assays (e.g., microsomes) and analysis

Understand and troubleshoot assay performance

Practical experience with solid-phase extraction and liquid-liquid extraction techniques for isolation of parent compound or metabolite(s) from biomatrices (blood, plasma, urine and/or various tissues)

Proficiency in report writing, including regulatory document summaries

Responsible for in-house and external inventory of bioanalytical samples

Provide direction of contract laboratories for assay validation, data, and report review


CORPORATE COMMITMENTS:


Demonstrate commitment and support for company goals, objectives, and procedures

Represent Reata by developing collaborative relationships with site personnel, colleagues, and vendors

Demonstrate professionalism and adherence to moral, ethical, and quality principles

Participate in corporate and departmental meetings

Comply with applicable regulations, guidance, corporate policies, and procedures


QUALIFICATIONS:


M.S. or PhD in relevant scientific field

8-10 years of combined experience with bioanalytical assay procedures and laboratory leadership

Work experience within a pharmaceutical company performing GLP bioanalysis is required

Experience in analytical problem-solving, presentation of solutions and communication to regulatory authorities

Knowledge of Good Laboratory Practices

Experience with regulatory submissions

Knowledge of Waters HPLC instruments and Waters software (MassLynx and Empower) and Agilent HPLC-MS systems

A working knowledge of drug metabolism and solvents/chemical characteristics

Experience leading bioanalytical work for the support of pharmacology research, including pharmacokinetics, pharmacodynamics and drug metabolism in pharmaceutical development

Demonstrated leadership experience with in vitro metabolism assays, i.e., microsomes, hepatocytes and S9 liver fractions

The ability to troubleshoot drug isolation from biologic fluid, analytical and instrumentation problems and perform routine instrument maintenance

The ability to manage multiple projects and deliverables and assign priorities

Good people and communication skills; ability to present and discuss data in team settings

Qualified candidates must be legally authorized to be employed in the United States


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