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Scientist I -Viral Clearance
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Scientist – Viral Clearance
As Scientist – Viral Clearance you will design and deliver Viral Clearance validation studies for biopharmaceutical companies across the China region. Within the Process Solutions 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 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 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, 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:
- Supports set-up of new facility and executes assay transfer and start-up of Viral Clearance lab operations
- Acts as Study Director 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 in 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)
- Leads investigations 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
- 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 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:
- Master degree in Biological Sciences or higher degree in relevant scientific subject
- 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
- 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).
- English fluency in speaking and writing.
- 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
Functional Area: Research & Development
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com