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Associate Director/Director, Bioanalytical Research

Regenxbio Inc.


Location:
Rockville, Maryland 20850
Date:
08/22/2017
2017-08-222017-09-22
Job Type:
Employee
Job Status:
Full Time
Regenxbio Inc.
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Job Details

The Associate Director/Director of Bioanalytical Research is responsible for leading a team of bioanalytical scientists and/or research associates to ensure that bioanalytical methods supporting REGENXBIO gene therapy products pipeline are developed, qualified and/or validated based on current regulatory expectations and REGENXBIO’s requirements. The Associate Director/Director of Bioanalytical Research will collaborate with other REGENXBIO Departments including R&D, Analytical Development, Quality, Clinical Development, and manage interactions with Contract Research Organizations to ensure that all applicable bioanalytical methods and systems are appropriate for the stage of non-clinical and/or clinical development and sufficiently qualified or validated to support ongoing and future studies. The Associate Director maintains broad knowledge of state-of-the-art principles and theories, and develops and analyzes new product concepts by reviewing preclinical and clinical literature.


PRIMARY RESPONSIBILITIES

  • Leads scientists and/or research associates to develop, qualify and/or validate robust bioanalytical methods to support the Company pipeline.
  • Manages the sample analysis of non-clinical and clinical specimen and ensures that appropriate compliance requirements are followed.
  • Troubleshoots bioanalytical method issues to successful resolution
  • Manages technology transfers between research organizations, in-house and contract laboratories.
  • Writes and/or reviews protocols, reports, SOPs, and documents for regulatory submissions
  • Hires and manages staff, provides training as needed, and ensures adherence to company policies and quality requirements.
  • Serves as an in-house consultant.
  • Synthesizes multiple data sources and draws general, non-obvious conclusions.
  • Defines complex problems, develops approaches and develops experiments with sound judgment.
  • May independently represent the Company to outside organizations.
  • Interfaces with various departments, customers and partners.
  • Puts work practices in context with larger team and participates in the implementation of change when required.
  • Plans and coordinates activities with other team members.
  • May assist with designing and implementing organizational processes, budgetary and capital equipment requirements, and identifies needs for additional resources.
  • Manages scientific investigations.
  • Performs additional tasks or assist with special projects as assigned or needed


Requirements

  • A PhD in a scientific discipline is required. Equivalent experience may be accepted.
  • Minimum 10 years industry experience and 2 years of experience working in a supervisory or managerial role.
  • Strong leadership, organizational and prioritization skills.
  • Demonstrated ability to analyze and resolve problems.
  • Demonstrated knowledge of regulatory agencies guidance documents and white papers
  • Prior experience working in regulated environment and knowledge of GLP and GCP as they apply to laboratory practices
  • Must possess excellent oral and written communication skills.
  • Ability to present technical information to both technical and non-technical audience is required
  • Must be able to demonstrate sound judgement
  • Must be able to demonstrate good interpersonal skills

TECHNICAL SKILLS

  • Strong technical expertise in areas such as Pharmacokinetics Assays, Cell-based Assays, Immunogenicity Assays, Biomarkers Assays and the respective bioanalytical technologies
  • Good computer skills and working knowledge of SoftMax or other data analysis software, MS word, Excel, Power Point are required.

MANAGER/SUPERVISORY RESPONSIBILITIES

  • Management responsibility of a team of 2-10 bioanalytical scientists/research associates

 

 

 

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