Global Project Lead - Impurity Testing
US - California - Remote / Field, US - Colorado - Remote / Field, US - Connecticut - Remote / Field, US - Florida - Remote / Field, US - Georgia - Remote / Field, US - Illinois - Remote / Field, US - Maryland - Remote / Field, US - Massachusetts - Remote Update time: August 19,2020
Job Description
This position can be based remotely.
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How will you make an impact?
The Global Project Lead – Impurity Testing, will be responsible for project management and process development for implementing emerging regulatory requirements related to potential Nitrosamine impurities in Drug Substance and Drug Product within a multinational pharmaceutical Contract Development and Manufacturing Organization. The position will be in the Global Quality Compliance Team within the Pharma Services Group.
What will you do?
- Develop a global process (es) that must effectively work for multiple sites within the Pharma Services Group and incorporate regulatory requirements from various regulatory bodies.
- Stay current on emerging regulations and information related to requirements and industry standards for evaluating and mitigating nitrosamine impurities.
- Interpret and distill the information for communication to site SMEs, Global Expert panel, and clients where applicable.
- Lead the Global Nitrosamines SME Forum to disseminate new information and requirements related to Nitrosamines.
- Facilitate the Global Expert Panel meetings for evaluation of drug substance and/or drug products that have potential risk of nitrosamine impurities.
- Establish global guidance document(s) outlining processes related to Nitrosamine risk assessment, risk mitigation, testing, and change management related to risk assessment documents.
- Help sites resolve or escalate challenging risk assessments as appropriate.
- Work with Business Management and Quotes teams to establish standards for nitrosamine related work.
- Drive continuous improvement to the Collaboration Space(s)
Bachelor’s Degree or higher in Chemistry, Biochemistry, Engineering, or other physical science.
Candidate with M.S. and/or Ph.D. in relevant discipline is preferred.
- Minimum of 7 years’ experience in a regulated industry (GxP) with direct pharmaceutical experience in QA, QC, R&D, or Regulatory Affairs
- Technical knowledge of impurities as required by ICH Guidelines
- Experience with Risk management principles
- Experience with external surveillance and searching for latest information related to nitrosamines
- Demonstrated ability to influence and lead professional staff in order to achieve goals
- Ability to evaluate and resolve complex technical problems by using network resources.
- Ability to communicate and develop an internal strategic network while working remotely.
- Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
- Strong written and verbal communication skills and effective presentation skills.
- Ability to travel up to 25% on an annual basis
This position has not been approved to provide relocation assistance
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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.
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