Project Lead, Clinical Quality Control Physico-chemical Analytics
Project Lead, Clinical Quality Control Physico-chemical Analytics
Lonza
Basel, Switzerland
Key Responsibilities:
- Lead pharmaceutical development projects for drug entities (mAB/protein) at all levels of complexity and new modalities (e.g. ADC, mRNA). Projects will involve QC, different clinical development phases, and market authorization readiness;
- Responsible for timely completion and submission of necessary documents and reports, including stability reports and LIMS specifications. Also leads change requests, CAPAs, and investigations of deviations and OOX events. Represents QC in internal and customer meetings as a subject matter expert;
- Maintain the cGMP quality standard for assigned processes in PhysChem QC according to applicable SOPs and current health authority/international guidelines (e.g. EMA, FDA CFR, USP, PhEur, JP, PIC/S, ICH);
- Coordinate with partner units and Lonza network to reliably deliver projects and implement safety regulations and Key Quality Indicators (KQI).
Key Requirements:
- MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry or related field with confirmed work experience in relevant area;
- Previous experience in protein analytics, specifically understanding protein degradation pathways and molecule liabilities. Preferably with a strong track record in a cGMP regulated area of the pharmaceutical or chemical industry, specifically in analytical quality control or Analytical Development of large molecule;
- Over 3 years’ working experience on the analytical lifecycle of biotechnology products, CMC requirements for regulatory filings required;
- Experience in cGMP Quality Control of Antibody-Drug Conjugates (ADC) and/or mRNA, either on Drug Substance and/or Drug Product level, is a strong advantage;
- Hands-on experience in management of quality records like deviations, CAPAs, Change Requests;
- Proficient in English.
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