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.
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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.