WHO WE ARE:

We are a leading science and technology company. Our life science business offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science. 

YOUR ROLE:

As Process Scientist – Viral Clearance you will design and 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 Merck 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.

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

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 and designs the execution strategy 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
• Leads by example, acts as subject matter expert, offers scientific coaching and mentoring to other staff members
• 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
• Designs, directs and leads complex projects related to area of operational expertise
• Writes protocols, Standard Operating Procedures (SOPs) and workbooks for projects and implements Change Control for new service introduction
• 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 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

 
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:

• Master degree in Chemical Engineering, Biological Sciences or higher degree in related scientific subject

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 in downstream bioprocessing (filtration and chromatography)
• Hands-on experience with Akta Pure/Avant systems
• 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

Knowledge & Skills:

• Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
• Ability to complete documentation (both handwritten and electronic) neatly and accurately
• Train the trainer
• English fluency in speaking and writing. Practical knowledge of Japanese and/or Korean is a plus.

Core competencies:

• Organization skills
  • Demonstrates customer centricity
  • Through effective communication, provides the information people need to know to do their jobs
  • Has strong organizational skills with the ability to use available resources effectively
• Problem solving and drive
  • Can learn new skills and acquire knowledge rapidly
  • Uses logic to solve complex problems and can troubleshoot effectively
  • Is self-motivated and action-orientated, determined to provide best-in-class service and seizes more opportunities than others
  • Pursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacks
  • Can be counted on to achieve goals, constantly and consistently, pushes self and others for results
• Professional and technical skills
  • Has the functional and technical knowledge and skills to do the job at a high level of accomplishment
  • Shows sound judgment in decision making
  • Comes up with new and unique ideas and adds value in brainstorming settings
  • Deals effectively with pressure; remains optimistic and persistent, even under adversity
  • Puts safety first by adhering to health and safety procedures and actively takes necessary action when encountering unsafe situations
• Personal and interpersonal skills
  • Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
  • Is seen as a team player, cooperative and encourages collaboration
  • Communicates effectively with others and handles conflict effectively
  • The ability to maintain effective working relationships with lab personnel, global and internal stakeholders will be critical for success in the role 

 
 ADDITIONAL LOCAL NEEDS

• Ability to work overtime or flexible shifts from time to time to cover testing requirements