Scientist - Viral Clearance (Molecular)

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**YOUR ROLE**:
As Scientist - Viral Clearance (Molecular) you will report to Viral Clearance Manager, mainly design and deliver Viral Clearance validation and as secondary role perform biologics safety studies for biopharmaceutical companies across the APAC region. Within theProcess Solutions Services team, you will have scientific expertise in Viral Clearance and biologics safety testing with in-depth understanding of Molecular Biology assays. You will ensure projects are carried out with the appropriate scientific and regulatory compliance oversight, and provide your scientific expertise to support investigations and client meetings.

Your responsibilities will include reviewing proposals, acting mainly as qPCR scientist on Good Laboratory Practice (GLP) studies and backup for (Good Manufacturing Practice) GMP studies, reviewing and monitoring assay performance and lead scientific trouble shooting discussions during investigations. You will also have the technical expertise to advice and support GLP and GMP operations and audits, and you will maintain an in-depth understanding ofBioReliance services and technical principles as well as advances in the field. The ability to maintain effective working relationships with clients (external) and development services, project management, sales and laboratory personnel (internal) will be critical for success in the role.

The post holder will be able to perform the following functions.

**Brief role description**:

- Leads assay transfer of qPCR qualification and endpoint assays
- Acts as qPCR Scientist for qPCR testing for Viral Clearance GLP studies, and GMP studies
- May act as a study director for GLP and GMP studies
- Works within the laboratory areas providing hands-on support, training, guidance and mentorship to laboratory based personnel on the areas of molecular biology, ensuring routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards
- Plans, organises and prioritizes workload to make sure resources are used efficiently and effectively to complete tasks and activities, including qPCR report (GLP) and Certificate of Analysis (CoA) (GMP)
- Responds to audit observations through the BioReliance Integrated Quality System (Trackwise)
- Leads investigation and progresses deviation and Corrective or Preventative Action (CAPA) records in a timely manner
- Works with Development Services and/or the Commercial team to review proposals
- Designs, directs and leads complex projects related to area of operational expertise
- Writes protocols, Standard Operating Procedures (SOPs) and workbooks for projects and raise and progress Change Control for new service introduction
- Reviews and authorizes study documentation and other technical / scientific documents, such as amendments
- Responsible for maintenance and scientific integrity of routine and non-standard assays methods by monitoring assay performance and ensuring all assays/ processes are in a validated state in line with current regulations
- Leads process improvements within the laboratory to improve quality and performance
- Acts as scientific consultant to support departmental investigations, client product queries, supplier audits and client/regulatory inspections
- Ensures all assays/ processes are in a validated state in line with current regulations
- Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures to ensure the welfare and safety of self and others within the workplace

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post.

**WHO YOU ARE**:

- Minimum 6-8 years of experience in a scientific laboratory role
- Minimum 2 years of experience in a regulated environment (GLP/GMP) preferred
- Demonstrable scientific and hands-on expertise in molecular biology and qPCR assays
- Demonstrable scientific understanding of virology and protein purification in the biopharmaceutical industry preferred
- Experience of working in Biosafety Level 2 laboratory
- Knowledge & understanding of GLP and GMP regulations, and guidelines on Viral Safety Assurance
- Knowledge of protein purification and downstream processing, with hands-on experience with lab-scale chromatographic systems preferred
- Computer literacy in GMP systems such as LIMS, ELN, Trackwise
- English fluency in speaking and writing

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