Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift
Job Description
Join an exceptionally ambitious team at Thermo Fisher Scientific Inc., where your skills as an AD Analyst will directly contribute to our world-class scientific research and development. We're looking for a proven professional who thrives in a collaborative environment and is passionate about flawless execution
Job Responsibilities
* Develop and optimize new or established analytical methods.
* Validate analytical methods, including issuing or upgrading validation reports, ensuring strict compliance with regulatory expectations.
* Manage change controls for analytical and instrument changes as required.
* Participate in technology transfer meetings and coordinate the procurement and installation of new equipment.
* Perform bench evaluations of key analytical methods, applying Quality by Design (QbD) principles.
* Provide technical support to Quality Labs during validation campaigns.
* Document training and proficiency testing and develop training materials.
* Carry out analysis and data review of AD sample testing, including non-routine and supplier assessment samples.
* Prepare reports detailing investigations and conclusions of quality issues.
* Support internal and external inspections, ensuring the AD laboratory is always ready.
* Troubleshoot laboratory equipment and manage service engineers as necessary.
* Engage in cross-functional teams to ensure timely completion of project achievements.
Job Requirements
* Bachelor's degree in Chemistry, Biochemistry, or a related field; advanced degree preferred.
* Minimum of 3 years of experience in analytical development and validation.
* Strong understanding of GMP compliance and regulatory requirements.
* Proven ability to lead technical projects and work effectively in cross-functional teams.
* Outstanding communication, facilitation, and presentation skills.
* Positive attitude, enthusiasm, and a can-do approach to problem-solving.
* Demonstrated leadership, influencing, and negotiating skills.
Become part of a team where your contributions will help determine and successfully implement innovative solutions to complex scientific challenges. Apply today and start your journey with us