Senior Consultant In Recruitment Life Science
Randstad seeks an Analytical Chemistry Specialist with expertise in peptides and drug substance analytics. This role is ideal for those with a strong technical background in this area and a desire to work with a leading company in the sector.
Responsibilities:
* Conduct analysis and characterization of peptides using various analytical techniques, including HPLC, LC-MS, CE, CD Spectrometry, NMR Spectroscopy.
* Define critical analytical parameters for peptides, such as purity, identity, and content, and validate these parameters.
* Confirm the use of validated methods for batch verification, including HPLC, LC-MS, and NMR.
* Oversee stability studies according to ICH guidelines to ensure peptide integrity in its solid form.
* Establish and maintain acceptance criteria for release testing, aligned with regulatory and internal quality standards.
* Review and approve Contract Manufacturing Organization (CMO) manufacturing processes, including:
* Drying and solidification techniques, such as lyophilization.
* Storage conditions, temperature, humidity, packaging.
* Use of excipients, if applicable.
* Identify 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 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 Good Manufacturing Practice (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.