AR&D Scientist II

5 days ago

High Point, United States Life Technologies (Thermo Fisher Scientific) Full time
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific, you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement solve cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Location/Division Specific Information
Work Location: High Point, NC (on-site)

Group: Pharma Services Group

Division: Drug Product Division

How will you make an impact

Responsible for developing or transferring analytical methods to support pharmaceutical process development. You will work within an interdisciplinary team of scientists where you will learn and supply your skills and ideas to projects.

What will you do

Perform laboratory experiments to develop, validate, or transfer methods to assess the potency, performance, and safety of new pharmaceutical products.

Interpret client documents and literature to strategize approaches for successful method development, qualification, and/or method transfer activities.

Responsible for performing in-depth analysis of analytical data and collaborate with the analytical team for method lifecycle review.

Communicate findings and discuss relevance of your data to a multi-discipline team consisting of upstream and downstream process development scientists, quality control, quality assurance, process engineers and our customers.

How will you get here

Education / Experience

Bachelors with 8 yrs. experience or Master's with 6 yrs. experience.

Knowledge and Technical expertise in performing analytical assessment on pharmaceutical products and raw materials including but not limited to high-performance liquid chromatography (HPLC), Gas Chromatography (GC), and Mass Spectrometry (MS).

Experience using analytical laboratory techniques to efficiently and accurately prepare sample and standard solutions for analysis.

Expertise in preparing protocols and reports to support regulatory filings.

Understand ICH/FDA method validation guidelines to assess method performance.

Ability to work independently with excellent communication, planning, and prioritization skills.

Experience working in a GxP environment and ALCOA+ documentation practices.

Passion for learning the analytical methods required for successful process development.

High attention to detail.

Strong desire to learning new skills.

Knowledge, Skills and Abilities

Exceptional communication skills with an astute attention to detail & accuracy

Strong understanding of change management principles, methodologies, and best practices

Ability to effectively engage and influence stakeholders at all levels of the organization

Exceptional analytical, problem-solving, and critical thinking abilities, with the capacity to assess risks and develop mitigation strategies

Ability to facilitate workshops, meetings, and training sessions to drive change initiatives

Strong organizational and project management skills

Ability to adapt to a fast-paced and dynamic work environment

Able to build effective relationships, influence people, drive accountability and resolve conflicts

This position has not been approved for relocation assistance.

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