About Batavia Biosciences
The reality is that we do much more than that: by leveraging the combination of our expert workforce, our broad, international academic and public network and our extensive range of high-end services, we design the optimal route for our customers to reach the one person that we all are 100% committed to: the patient.
The short version is that Batavia Biosciences helps to optimize the route from drug discovery to clinic.
To help us take biopharmaceutical development to the next level, our team would love to welcome you as our new QC Scientist within our Assay department to strengthen our team.
About the job
At our Leiden location, the Assay department is responsible for all tests and controls that are performed on purified and in-process biopharmaceutical samples (e.g. viral vaccines and viral vectors) for product release, stability studies and in-process sample monitoring. As a QC scientist you will be involved in all stages of a GMP campaign. You will work with the team to determine the testing required for release of the GMP material produced in our GMP facility as well as overseeing the outsourcing to third parties of assays that are not performed in-house. You will also be responsible for the qualification and validation of a wide spectrum of analytical and biochemical assays performed at QC level to support product characterization, as well as GMP operations. You will be involved in writing and reviewing documentation required during GMP campaigns, writing and reporting stability studies, assay qualifications and procedures as well as take part in investigations into quality.
You will join an enthusiastic group of international scientists and technicians that work in a very collaborative environment. As part of this group, your personal as well as your scientific growth are encouraged and developed. You will be reporting to the Head of QC.
- Coordinate and manage QC experiments in collaboration with a team
- Define and prepare the Bill of Testing for production of GMP material
- Participate in the review of the documentation for each GMP campaign
- Organize the execution of in-house testing
- Organize and oversee the outsourced testing at third party
- Report release testing results
- Oversee qualification and validation of assays for GMP application
- Participate in quality investigations and CAPA initiatives as needed
- Ensure that QC and regulatory guidelines are followed
- Train, develop, coach and mentor other personnel in Quality Control
- Ensure that EHS regulations are followed by team members
- A Master or PhD degree in life science, biotechnology or pharmacy or related subject
- Relevant experience in a biotechnology or biopharmaceutical industry or manufacturing environment involving techniques supporting cell-based and virus-based assays.
- Experience with assay qualification and / or validation
- Experience, knowledge and understanding of the QC methods and ICH guidelines
- GMP experience would be welcome
- Experience with biopharmaceutical process development is favourable
- Fluency in English both verbal and technical writing skills
- At least 2-5 year relevant work experience
You can send your application to Mrs. Ingrid van Aarle, HR Director, email firstname.lastname@example.org
Application by agencies or recruiters is not appreciated and will be rejected.