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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
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
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:
Master degree in Biological Sciences or higher degree in relevant 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 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
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
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
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