Process Scientist

**YOUR ROLE**:
As Process Scientist - Viral Clearance, you will deliver Viral Clearance validation studies for biopharmaceutical companies across the APAC region. Within the Process Solutions Services team, you will have scientific expertise in Viral Clearance with in-depth 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 you will provide technical expertise during client meetings, lead technology transfer of client processes, oversee the generation of batch records, coordinate execution of scale-down process in the lab and lead technical trouble shooting and 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 BioReliance 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, quality, sales and laboratory personnel (internal) will be critical for success in the role.

Brief role description:

- Acts as Process Scientist for viral clearance studies and holds responsibility for process aspects of client studies, including collection of client process information, generation of process records and Akta methods, client communication of results, resolving process issues and ensuring on time delivery of complete clearance studies
- Works within the viral clearance laboratory providing hands-on support, training and guidance to laboratory based personnel in the areas of process science, chromatography, virus filtrations and lab-scale downstream models
- Effectively collaborates with study management, testing lab functions, quality and PMO to ensure routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards
- Plans to successfully transfer client processes into the BioReliance laboratories according to the client’s technical documentation and SOP’s
- Prepares high quality client process specific protocols and methods for the performance of chromatography, inactivation and filtration steps
- 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
- Leads complex projects related to area of operational expertise
- Leads the set up of new process technology to be performed in Client Labs.
- Leads process improvements within the laboratory to improve quality and performance
- Acts as process science and technical consultant to support departmental investigations, client process queries, supplier audits and client/regulatory inspections
- 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

**WHO YOU ARE**:

- Minimum 4 to 6 years of experience in a scientific laboratory role (preferably with 2-3 years of experience in leading scientific project)
- Minimum 2 to 3 years of experience in a regulated environment (GLP/GMP) preferred
- Demonstrate scientific understanding in downstream bioprocessing (filtration and chromatography)
- Hands-on experience with Akta Pure/Avant systems, with demonstrated ability to program AKTA methods, and able to perform effective trouble-shooting in lab procedures
- Able to customize scale-down system set-up for non-routine client processes is a bonus
- Experience in setting up laboratory is a bonus
- Quality mindset and advanced understanding of Good Manufacturing/Laboratory Practices
- Prior experience in any of the following areas will be desirable:

- Prior experience in a regulated environment (GLP/GMP
- Prior experience in MSAT or Process Development (protein purification) in a biopharmaceutical company or related industry
- Experience of working in Biosafety Level 2 laboratory
- Experience of BLA, IND dossier preparation is a plus
- Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
- Ability to work overtime or flexible shifts from time to time to cover testing requirements.