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Senior Consultant In Recruitment Life Science
Randstad is looking for an Analytical Chemistry Specialist with experience in peptides and drug substance analytics. If you have a strong technical background in this area and want to work for a leading company in the sector, this opportunity is for you.
Responsibilities:
* Conduct analysis and characterization of peptides using various analytical techniques.
* Ensure that all critical analytical parameters for peptides — such as purity, identity, and content — are properly defined and validated.
* Confirm the use of appropriate, validated methods for batch verification, including HPLC, LC-MS, and NMR.
* Oversee stability studies according to ICH guidelines to ensure the peptide maintains integrity in its solid form.
* Set and maintain acceptance criteria for release testing, aligned with regulatory and internal quality standards.
* Review and approve the CMO’s manufacturing processes, including:
* Drying and solidification techniques (e.g., lyophilization).
* Storage conditions (temperature, humidity, packaging).
* Use of excipients, if applicable.
* Define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) relevant to solid-state peptides — such as residual solvents, moisture content, and solid form stability.
* Ensure appropriate controls are in place to detect impurities or degradation, such as aggregation, oxidation, deamidation, and racemization.
* Review and approve the analytical methods used by the CMO to ensure they meet regulatory and scientific standards.
* Oversee identity testing (to confirm correct amino acid sequence) and impurity profiling.
* Ensure that all testing and controls at the CMO are performed under GMP-compliant conditions.
* Participate in batch record review and deviation management, including the evaluation of borderline or out-of-specification results.
* Monitor ongoing trend analysis to identify potential quality or process issues early.
Requirements:
* 5 to 10 years of experience in analytical chemistry applied to peptides.
* Proficiency in analytical techniques for peptides, including HPLC, LC-MS, CE, CD Spectrometry, NMR Spectroscopy.
* Experience in method development and validation.
* Familiarity with GMP regulations and pharmaceutical compliance standards.
* Advanced English proficiency (mandatory), German knowledge is a plus.
* Ability to work in a team and in a highly regulated environment.
If you meet the requirements and are interested in this position, please send your updated CV.
We look forward to meeting you soon!
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science and Quality Assurance
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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