Scientist - Biosafety Testing (Lot Release)

Posted 21 Jan 2019

Singapore - all, Singapore - Singapore

Req Id 183839

Details

A career at our company is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


 

Your role:

The Scientist will have scientific expertise in biologics safety testing focused primarily on microbiology, also knowledge on cell biology, virology and molecular biology. They will ensure projects are carried out with the appropriate scientific and regulatory compliance oversight. They will also provide their scientific expertise to support investigations and client meetings. The post holder will have the technical expertise to advice and support GLP / GMP operations. Responsibilities include reviewing proposals, acting as study director/responsible scientist on complex technical projects, responding to routine assay sales enquiries, reviewing and monitoring assay performance and lead scientific trouble shooting discussions during investigations. They 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 development services, sales and laboratory personnel will be critical for success in the role.

The post holder will be able to perform the following functions independently, with minimal guidance.

 

Brief role description:

  • Acts as a Study Director or Responsible Scientist for routine and complex assays and as such holds responsibility for the overall conduct of GLP or GMP studies, respectively.
  • Plans, organises and prioritizes workload to make sure resources are used efficiently and effectively to complete tasks and activities.
  • Works within the laboratory areas providing hands-on support, training, guidance and mentorship to laboratory (microbiology, cell biology, virology and molecular biology) based personnel, 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 scientific 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 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.
  • Review and write Genetically Modified Organism (GMOs) risk assessments.
  • 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.
  • Acts as point of contact for routine study sales enquiries.
  • Ensures all assays / processes are in a validated state in line with current regulations.
  • Acts a lab liaison for microbiological environmental monitoring and quality control.
  • 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. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post

 

Who you are:

Education:

  • Master’s degree or higher in Biological Sciences or relevant scientific subject

     

Experience:

  • Minimum 8 years of experience in a scientific laboratory role, ideally within a GLP / GMP contract testing laboratory environment
  • Demonstrable scientific expertise in microbiology, virology, cell culture related works
  • Understand molecular biology would be advantageous.
  • Experience of working in Biosafety Level 2 laboratory.
  • Client facing, regulatory inspection experience would be advantageous.

 

Knowledge & Skills:

  • Computer literacy and entry of data into databases (LIMS, ELN, SAP, Oracle, Trackwise, etc.)
  • Ability to complete documentation (both handwritten and electronic) neatly and accurately
  • Train the trainer
  • Core competencies:
    • Demonstrates customer centricity
    • Can troubleshoot effectively
    • Plans workload by assigning tasks appropriately depending on length and difficulty of task
    • Self-motivated; is action-orientated
    • Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration

 


What we offer: At our company, 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!

 

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