Senior Scientist - Stability Testing, GMP
Welcome to Thermo Fisher Scientific, a global leader in serving science. We are currently seeking a highly experienced and motivated Senior Scientist to join our Stability Testing team. In this role, you will play a critical role in ensuring the quality and efficacy of our pharmaceutical products through the application of Good Manufacturing Practices (GMP). As a Senior Scientist, you will lead and support stability studies for new and existing products, using your expertise in analytical techniques and regulatory compliance to drive success. If you are a dedicated and detail-oriented professional with a strong background in stability testing and GMP, we encourage you to apply and make a significant impact on our organization.
- Lead and oversee stability testing for new and existing pharmaceutical products in accordance with GMP guidelines.
- Utilize advanced analytical techniques to ensure the quality and efficacy of products.
- Develop and implement stability protocols and testing methods.
- Analyze and interpret stability data to identify trends and potential issues.
- Collaborate with cross-functional teams to ensure timely completion of stability studies.
- Support regulatory submissions by providing stability data and documentation.
- Train and mentor junior scientists on stability testing and GMP requirements.
- Identify and implement process improvements to enhance efficiency and compliance.
- Maintain accurate and organized documentation of all stability testing activities.
- Stay current on industry trends and regulations related to stability testing and GMP.
- Communicate effectively with internal and external stakeholders regarding stability testing results and recommendations.
- Collaborate with Quality Assurance to address any stability-related issues or deviations.
- Participate in internal and external audits as a subject matter expert on stability testing and GMP.
- Contribute to the development and optimization of stability testing procedures and methods.
- Demonstrate a strong commitment to quality and drive a culture of continuous improvement within the Stability Testing team.
Advanced Degree In A Scientific Field: A Senior Scientist In Stability Testing At Thermo Fisher Scientific Must Possess At Least A Master's Degree In A Relevant Scientific Field, Such As Chemistry, Biochemistry, Or Pharmaceutical Sciences.
Extensive Experience In Stability Testing: The Ideal Candidate Should Have A Minimum Of 5 Years Of Experience In Stability Testing Within A Gmp Environment. This Includes Experience With Various Analytical Techniques, Such As Hplc, Gc, And Dissolution Testing.
Knowledge Of Gmp Regulations: Thermo Fisher Scientific Is A Highly Regulated Company, So The Senior Scientist Must Have A Thorough Understanding Of Current Good Manufacturing Practices (Cgmp) And Other Relevant Regulations, Such As Fda, Ich, And Ema Guidelines.
Leadership Skills: This Position Will Involve Managing A Team Of Scientists And Technicians, So Strong Leadership Skills Are Essential. The Senior Scientist Must Be Able To Provide Guidance, Training, And Mentorship To Their Team To Ensure Accurate And Timely Completion Of Stability Testing Projects.
Strong Communication And Problem-Solving Abilities: As A Senior Scientist, The Candidate Must Be Able To Effectively Communicate With Cross-Functional Teams, Present Data And Results To Management, And Troubleshoot Any Issues That May Arise During Stability Testing. They Must Also Be Able To Adapt To Changing Priorities And Timelines To Ensure Successful Project Completion.
Project Management
Data Analysis
Problem Solving
Technical Writing
Quality Control
Experimental design
Team Leadership
Regulatory compliance
Analytical Chemistry
Laboratory Techniques
Method development
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Scientist - Stability Testing, GMP in Boston, MA, USA is $100,000 - $130,000 per year. This can vary depending on factors such as the specific industry, company, and years of experience.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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