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Technical Director – Chemistry

Brief Job Summary:                              

The Technical Director is responsible for providing customer support and technical guidance for extractable/leachable and related programs for container closures, delivery systems and disposables for biologics and pharmaceutical applications

Position Responsibilities:

  • Uses knowledge of industry standards including FDA and ICH guidance to provide to provide strategic direction as well as technical support to staff.
  • Interacts with client to discuss project planning and testing requirements.
  • Interacts with internal staff and management to identify assay requiring further improvements or development and oversees improvement of these assays.
  • Facilitate communication between members of the study team and sponsor.
  • Follow up with clients as needed.
  • Interaction with internal and external clients and laboratories.
  • Develop and maintain protocols.

Position Specific Responsibilities:

  • Attend conference calls and write project proposals.
  • Dedicated management of clients.
  • Work with multiple internal and external laboratories to ensure accurate and on-time project completion.
  • Receive and review reports to ensure accuracy, consistency and professional appearance.

Position Qualifications:

  • Detail Orientated with Strong Organizational skills
  • Proficient in Microsoft Word, Excel and Windows based programs
  • GLP/GMP Experience, experience as GLP Study Director a plus.
  • Strong Understanding of Biologics development and submission requirements.
  • Basic Understanding or previous experience analytical techniques with LCMS, GCMS and/or ICPMS preferred
  • Outstanding customer service, organizational and analytical program/project management skills
  • Bachelors Degree or equivalent life science or Biotech experience.
  • Minimum of 10 years of experience

To apply please click on this link:https://home.eease.adp.com/recruit/?id=10082291