WuXi AppTec

Senior Scientific Director

US-MN-St. Paul
Job ID
2017-3100

Overview

The Sr. Scientific Director is responsible for scientific leadership of the St Paul site, including Medical Device and Biologic testing services, which include in vivo and in vitro biocompatibility services, as well as toxicology and risk assessment consulting services.

 

Responsibilities

 

  • Oversees scientific program for all aspects of biocompatibility and biologic testing (cellular and gene therapy preclinical testing with toxicology, biodistribution and tumorgenicity studies), and ensures scientific integrity and regulatory compliance.
  • Serves as a technical expert by assisting the laboratories with study design, data interpretation, failure analysis, and corrective actions.
  • Coach and mentor employees and be an advocate for them and the organization.
  • Involved with industry committees, build scientific programs within company and prepare WuXi AppTec presentations for committees or scientific conferences and meetings.
  • Support business development and marketing efforts, as necessary.
  • Maintain up-to-date knowledge of applicable guidelines and regulations.
  • Evaluate performance and workload, and provide training and development.
  • Thorough understanding and experience with Good Laboratory Practices.
  • Ability to work in a team environment and independently, as required.
  • Contribute to the overall operations and to the achievement of departmental, site, and company goals.
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • Attend scientific conferences and meetings, as needed.
  • Other duties, including assisting in multiple departments, as assigned.

 

Qualifications

 

Experience / Education

  • MS in toxicology, immunology, biochemistry or virology or related scientific/engineering field and over 15 yrs experience.   Preferred background: PhD/DVM in toxicology, immunology, biochemistry or related scientific/engineering field in preclinical studies and research, and over 10 yrs experience.
  • Experience in customer communications across the medical device and biopharmaceutical industry
  • Experience conducting/monitoring toxicology studies for the medical device and/or biopharmaceutical and pharmaceutical industry
  • Experience in animal surgery, animal care, cell or molecular biology, and/or biomaterials desirable
  • Experience with medical device testing
  • Minimum 5 years management experience with direct reports
  • Experience in CRO preferred

 

Knowledge / Skills / Abilities:

  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)
  • Experience with GLP
  • Understanding and experience writing SOPs, study protocols and study reports
  • Experience with statistical analyses
  • Experience as a study director with focus on in vivo studies
  • Experience with professional development of scientific staff
  • Must be able to travel, as needed

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to work in environment with variable noise levels
  • Ability to stand /sit for long periods of time
  • Clarity of sight to perform tasks detailed above
  • Inside working conditions

 

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