Senior Development Expert

6 days ago


Limerick, Limerick, Ireland SPEEDECK Full time

Job Overview:

SPEEDECK is seeking a seasoned Senior Specialist in Analytical Development to spearhead the creation and refinement of analytical methods. This role is pivotal in ensuring the successful development and production of high-quality medical products, collaborating closely with internal teams and external stakeholders.

Responsibilities:

  • Design, develop, and improve analytical methods to support product development.
  • Provide expertise in resolving technical challenges and facilitating technology transfers.
  • Coordinate project plans to align analytical validation efforts with broader development timelines.
  • Oversee routine testing to support product development and ensure accurate results.
  • Lead risk assessments and ensure adherence to relevant regulatory standards.
  • Mentor and guide team members to foster a collaborative and productive environment.
  • Deliver clear and actionable recommendations to inform technical strategies and decisions.
  • Review and approve work completed by team members, including validation data and testing reports.
  • Maintain thorough and compliant documentation for all processes and results.

Qualifications:

  • Bachelor's degree in Chemistry, Analytical Science, or a closely related field.
  • Significant experience in developing and validating analytical methods.
  • In-depth knowledge of regulatory requirements such as ICH guidelines and GMP standards.
  • Proven experience in a leadership or supervisory role within a technical setting.
  • At least four years of experience in analytical development within the pharmaceutical or medical device industry.

Skills and Competencies:

  • Strong problem-solving skills with a proactive approach to challenges.
  • Excellent written and verbal communication abilities.
  • A team player who can build positive working relationships and foster collaboration.
  • Demonstrates a strong commitment to quality and delivering exceptional results.
  • Organized and detail-oriented, with the ability to manage multiple tasks effectively.


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