Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

What will you do?

Develop Strategies and the implementation of change management plans for Supply Chain/Procurement projects of all sizesCreate and manage communication plans to keep employees informed and engaged throughout each project.Monitor change efforts, gather feedback and find ways to continuously improve our approach.Collaborate with cross-functional teams to find opportunities to optimize new incoming materials.Assess the impact of alternative components and bring design solutions that streamline testing and qualification efforts.Work with multi-discipline colleagues to author, submit and implement change controls through the quality system. These changes will encompass new part numbers, changes to incoming material specification and material designs.Drive efficiency and value through the standardization and cataloging of consumables.Update standard operating procedures as necessaryOther duties may be assigned to meet business needs.

How will you get here?

5-7 years of relevant experience or an equivalent combination of education, industry technical training and experience.Direct experience supporting biologic manufacturing processes within an FDA/EMA regulated environment preferredExperience in use of change management systems such as Trackwise.Experience with single-use technologies & other biotech raw materials is highly desirable.Must have an understanding of general cGMP standards and industry change management best practicesChange Manager Certification (CMS) a plusAbility to develop and execute strategies that enhance adoption and minimize resistance

Knowledge, Skills, Abilities

Strong interpersonal and communications skills; written and oralAble to manage multiple priorities with varying degrees of complexity in parallel.Strong understanding of applicable regulatory requirementsTechnical documentation review and revision experienceStrong ability to work independentlyA collaborative approach to problem-solving that builds agreement and support, bringing together different teams to achieve desired results.Comfortable supporting concurrent issues and working in an exciting, fast-paced environment.

Education:

Bachelor's Degree from an accredited College or University in Life Science, Engineering or Business Discipline is preferred.

Thermo Fisher Scientific Inc. is proud to be an Equal Opportunity Employer (EOE) and provides reasonable accommodations to individuals with disabilities. We embrace diversity and encourage individuals from all backgrounds to apply.