Analytical Development Scientist - Contract - Bristol, PA
Ready to assist in bringing life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
Primary Responsibilities:
You will be instrumental in ensuring data integrity, reviewing laboratory notebooks, and supporting GMP-related documentation processes. This role requires attention to detail and a collaborative approach to meet development goals.
Skills & Requirements:
- Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- Expertise in separation-based analytical techniques like HPLC, GC, and CE-SDS.
- Experience in reviewing laboratory notebooks and GMP documents.
- Familiarity with method development and qualification principles.
- Proficiency in document management systems is advantageous.
- Knowledge of stability testing and ICH guidelines is preferred.
- Understanding of regulatory expectations for early-phase clinical development.
- Experience with IND filings and analytical data trending is beneficial.
The Analytical Development Scientist's responsibilities will be:
- Review laboratory notebooks for completion, compliance, accuracy, and clarity.
- Evaluate the suitability of analytical methods and data for development objectives.
- Provide technical support for separation-based assays, including HPLC, GC, and CE-SDS.
- Review analytical methods for compliance with internal standards and GMP requirements.
- Assess qualification protocols and reports for methods transitioning to quality control.
- Support the preparation and review of development reports.
- Assist in generating Certificates of Testing for batch release and stability assessments.
- Ensure all data and documentation adhere to regulatory and internal compliance standards.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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