About the Role
We are looking for a Scientist in QC Microbiology to join a growing quality control laboratory within an advanced pharmaceutical manufacturing environment. In this role, you will act as a subject matter expert for microbiological methods, supporting routine testing, method transfer and validation activities. You will play a key role in leading CAPA and deviation/investigation tasks, and supporting continuous improvement initiatives within the QC laboratory.
Key Responsibilities
- Act as a technical subject matter specialist for microbiological method transfer, verification and validation, as well as routine testing of in-process, finished product and stability samples.
- Review and assess microbiological test results and related documentation, including data packages, batch documentation and Certificates of Analysis.
- Independently identify, investigate and resolve complex technical issues and deviations.
- Perform detailed data checks, data reviews and GMP documentation reviews across multiple methods and/or products, including complex assays.
- Lead and take ownership of projects, deviation investigations, CAPAs and continuous improvement initiatives.
- Represent the QC department during internal reviews, external audits and regulatory inspections when required.
- Provide training, coaching and ongoing support to colleagues across multiple QC microbiology methods, processes and procedures.
- Maintain cross-functional expertise through cross-training on various advanced microbiological methods and product types.
- Prepare, update, review and approve technical documentation such as SOPs, test methods, specifications, trend analyses and sampling plans.
- Perform additional duties as necessary to support daily operations within the QC laboratory.
Key Competencies
- Strong technical expertise in microbiological testing and GMP environments
- Analytical mindset with the ability to independently resolve complex technical issues
- Experience leading investigations, deviations and CAPAs
- Ability to work effectively both independently and within cross-functional teams
- Strong attention to detail and documentation accuracy
- Excellent communication and collaboration skills
Requirements
- Bachelor’s degree (HBO/HLO) or higher in Life Sciences, Microbiology, Biotechnology or a related field
- 6+ years of relevant experience in microbiological testing or QC experience
- Solid knowledge of microbiological techniques (e.g. bioburden, endotoxin, sterility testing)
- Experience with method validation/transfer is preferred
- Fluency in English, both written and spoken
Practical Information
- Location: Leiden, Netherlands
- Contract Duration: 12 months (fixed-term)
- Start Date: ASAP
- Work Model: Full-time, On-site