QC Molecular Biology Analyst

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Job description

Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) recognizing the sense of urgency in areas of high medical need.

*Position in the organization*

The Quality Control (QC) department is responsible for monitoring the quality of our AAV-based products, and the quality of the raw materials and starting materials used. These activities are all performed in accordance with cGMP guidelines, and are supported by departmental and inter-departmental policies and standard operating procedures.

*Main purpose of the job*

Helping to raise a QC organization.
The QC Molecular Biology Analyst role is responsible for performing testing of process intermediates, drug substance and drug product as well as virus and cells banks at the client' state of the art facility located in Amsterdam. This role will liaise with other functional groups, including Analytical Development and Quality Assurance.

*Key result areas (major duties, accountabilities and responsibilities)*:

* Participate in equipment validation, method transfer/validation Establish, revise, review and maintain procedures (including protocol and technical report).
* Oversee sampling and storage of QC samples and maintain retain inventory.
* Maintenance of laboratory equipment/instrument and systems to ensure compliance.
* Perform routine/non-routine testing of in-process, drug substance, final product, virus banks, cell banks in accordance with Standard Operating Procedures. Techniques include qPCR, ddPCR, cell-based assays, chromogenic assays, TCID50, etc.
* Perform all work in a cGMP environment.
* Perform work using aseptic technique.
* Cell Maintenance, Cell Passaging, Cell Counting, Cell culture and work with live viruses.
* Supports cGMP Quality Control operations through execution of Quality Management Systems including, but not limited to deviations, out of specification results, corrective and preventive action (CAPA), and change control.
* Actively review cell banks and virus bank testing policies and SOPs to ensure continuous compliance with regulations.
* Identify and implement Continuous Improvements.
* Perform quality metric trending as required.
* Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
* Troubleshooting equipment and testing methods.
*Education and Skills*

* A minimum of a Bachelor's degree in (Bio)Chemistry/Pharmacy, (Bio)Process Technology or equivalent.
* 1-3 years of relevant experience in pharma biotech company with laboratory experience in a QC testing capacity within cGMP setting.
* Large molecule, gene or cell therapy knowledge is required.
* Knowledge in molecular biology and viral assays including potency.
* Understanding of industry and regulatory testing requirements.
* Good/effective communication and organizational skills with the ability to work well with others and independently.
* Ability to manage activities with challenging timelines.
* Ability to work well with diverse groups.