Scientist I

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**YOUR ROLE**:
As Scientist - Viral Clearance you will design and deliver Viral Clearance validation studies for biopharmaceutical companies across the APAC region. Within the Life Science Services team, you will have scientific expertise in Viral Clearance with understanding of biopharma downstream processing (chromatography, virus filtration and low pH/chemical inactivation) and virology. 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 as study director/QPCR scientist on GLP 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 / GMP operations and audits, and you will maintain an in-depth understanding of Contract Testing 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**:

- Acts as a study director or QPCR scientist for viral clearance validation studies and as such holds responsibility for the overall conduct of Good Laboratory Practice (GLP) studies
- Plans, organises and prioritizes workload to make sure resources are used efficiently and effectively to complete tasks and activities
- Works within the viral clearance laboratory areas providing hands-on support, training, guidance and mentorship to laboratory based personnel on the areas of virology, cell culture, chromatography & filtration, as required whilst ensuring routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards
- Responds to audit observations through the BioReliance Integrated Quality System (Trackwise)
- Raises 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 advising and implementing on improvements where necessary
- Writes and approves safety and quality risk assessments as and when required
- 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**:
**Education**:
**Experience**:

- Minimum 8 years of experience in a scientific laboratory role
- Minimum 2 years of experience in a regulated environment (GLP/GMP) preferred
- Demonstrable scientific understanding of protein purification in the biopharmaceutical industry (filtration & chromatography)
- Experience of working in Biosafety Level 2 laboratory
- Prior experience in cell culture and/or virology would be advantageous

**Knowledge & Skills**:

- Knowledge & understanding of GLP / 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 (LIMS, ELN and Trackwise).

**Core competencies**:

- Strategy and organization skills
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