Keywords
- QC
- Regulatory filing (BLA)
- Microbial detection
- ICH
- Risk assessment
Profile
For one of our clients, we are looking for a Senior Scientist QC with a focus on microbial detection. They are implementing state-of-the-art automated (rapid) assays, and looking for someone who can ensure their QC methods are compliant with the required quality systems and regulations.
Your responsibilities are:
- Implement and improve the sterility assurance strategy, develop contamination control plans, conduct risk assessments;
- Provide scientific input for in-process control testing, release & stability, analytical development, tech transfer etc. for teams in both the EU and US;
- Author and review regulatory documents, filings, and communications (BLA/IND/IMPD);
- Lifecycle management of analytical methods, including verification and validation;
- Lead Out of Specification and Out of Trend investigations;
- Change Control management, impact assessments and implement CAPA’s;
- Coach peers, scientists, and technicians.
Who we're looking for
The ideal candidate has an M.Sc. with at least 5 years of relevant experience or a Ph.D. with at least 2 years of relevant experience, both in pharmaceutical industry, ideally, you have experience with Cell Therapy.
We are looking for someone with extensive knowledge of the latest rapid microbial detection techniques (sterility and endotoxin testing) and who is proficient in applying ICH Guidelines, cGMPs, EP/USP for cell therapies, and Annex 1.
Do you have experience with authoring risk assessments and regulatory filings (ideally BLA/IND/IMPD), are you able to motivate others and do you have strong interpersonal skills? Then we are looking for you!
Company profile
International Biotechnology company, located in Leiden.
Additional vacancy information
| Reference | : | A2400048 |
| Contract | : | Direct contract with client |
| Education | : | WO/MSc.
PhD. |
| Employment terms | : | On-site role |
| Publication date | : | 10-9-2024 |
| Location | : | View location with Google Maps |
| Contactperson | : | René Kemps |
| | +31 (0)88 22 77 555 |
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.
