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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 sizes

+ Create 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 necessary

+ Other 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 preferred

+ Experience 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 practices

+ Change Manager Certification (CMS) a plus

+ Ability to develop and execute strategies that enhance adoption and minimize resistance

Knowledge, Skills, Abilities

+ Strong interpersonal and communications skills; written and oral

+ Able to manage multiple priorities with varying degrees of complexity in parallel.

+ Strong understanding of applicable regulatory requirements

+ Technical documentation review and revision experience

+ Strong ability to work independently

+ A 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.