R&D Partnres is seeking an Analytical Development - QC Manager to join a biotech organization in Switzerland, on a full-time contract basis. In this role, you will oversee analytical development and quality control activities for late-stage drug development and commercial programs. You will work closely with external laboratories, ensuring compliance with quality standards, GMP, and regulatory guidelines.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
* Manage analytical development and quality control for assigned drug programs.
* Coordinate with external labs to ensure timely delivery of clinical trial materials.
* Supervise third-party labs for analytical tasks such as purity, stability, and impurity testing.
* Develop, optimize, and implement analytical methods at external labs.
* Represent the analytical team in project and CMC meetings.
* Oversee release, retest, stability studies, and validation analyses conducted by service providers.
* Ensure proper documentation of all analytical activities following Good Documentation Practices.
* Review and interpret analytical data, including method development and validation results.
* Draft and review protocols, reports, specifications, and other related documents.
* Evaluate and develop novel analytical techniques as needed.
* Support regulatory submissions by generating and reviewing quality-related data packages.
* Monitor program budgets and provide financial forecasts.
* Lead external lab work for troubleshooting, deviations, and other analytical tasks.
* Set and achieve product development timelines in collaboration with project leads.
* Communicate results and quality issues to management effectively.
Key Skills and Requirements:
* Educational background in chemistry, biochemistry, pharmacy, biology, or chemical engineering.
* Strong knowledge of GMP and regulatory requirements.
* Solid expertise in analytical chemistry and pharmaceutical sciences.
* Experience with analytical tests for drug substances and products.
* Ability to manage professionals in a matrix system and meet deadlines.
* Proficiency in documentation, timeline management, and communication.
* Familiarity with synthetic chemistry, drug substance processing, or formulation development is a plus.
* Experience interacting with regulatory agencies is advantageous.
For more information, please contact
Grant Van Schalkwyk
.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
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