
Scientific Development Specialist
1 week ago
Job Overview
Senior Analytical Scientist Role- This position plays a pivotal role in developing analytical methods and technologies for clients in the pharmaceutical industry.
Main Responsibilities:
- Develop scientifically sound approaches to create new analytical methods, leveraging technical expertise and client requirements.
- Provide on-site guidance as a Subject Matter Expert (SME) for various instrumentation, techniques, and technologies within a GMP/GLP environment.
- Evaluate technical options to optimize quality, economics, ease of implementation, and robustness in analytical applications.
- Validate in-house developed methods and transferred methods from clients through experimental design or other specialty methodology.
- Lead project discussions with clients regarding project definitions, technical information exchange, and status updates.
- Review protocols, project reports, and other technical documents for accuracy and compliance.
- Develop SOPs, quality systems, innovative technologies, and evaluate new capabilities.
- Analyze data for technical, quality, and compliance purposes, performing self and peer review prior to submission.
- Bachelor's degree in a relevant scientific field (e.g., chemistry, biochemistry).
- Minimum 10 years of relevant experience in a GMP laboratory environment.
In some cases, an equivalent combination of education, training, and/or experience may be considered sufficient.
Knowledge, Skills & Abilities- Effective written and oral communication skills.
- Industry best practices knowledge and application.
- Method development, validation, and regulatory experience.
- Strong understanding of general chemistry and separation science.
- Ability to adapt to changing regulations and technical limitations.
- Familiarity with SOPs, ICH guidelines, USP requirements, and FDA guidance.
- Technical writing abilities and teamwork.
- Problem-solving, time management, and project management skills.
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