Job Summary:
This position will handle daily testing and support activities connected with method development and validation projects on Drug/Device Combination Products. Duties will encompass analytical transfer and validation per regulatory guidelines, as well as completing lab investigations into analytical challenges encountered during method development.
Abilities / Experience
* Validate analytical methods across a number of techniques, including HPLC, particulate matter and dissolution
* Conduct analytical testing using a range of techniques
* Offer analytical support in technical transfer and troubleshooting
* Exhibit problem-solving skills in delivering process and analytical insights
* Comprehend the requirements for working within a GMP environment
* Ability to swiftly learn new procedures
* Excellent communication skills and the ability to build strong working relationships with colleagues
* Work independently and develop solutions to problems
* Be a good team player, organized, precise, and have strong documentation skills
* Commitment to quality and customer service
* Effective communication skills both internally and externally
Qualifications
* A degree in Chemistry or a related field is required, with at least 2 years of experience in a GMP laboratory
* Knowledge of method validation and HPLC testing experience is essential
* Dissolution experience is advantageous
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