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if you want to work:

in one of the most modern biotechnology
centres in Europe
 
in place where profesionals
from all over the world work
on the highest-quality equipoment
 
in the production
of biotechnological
drugs, which dive access
to effective therapy to
more patients
 
in a company that will dive you stable employment competetive remuneration attracive benefits and the opportunity to participate in training at home and abroad
 
Currently we’re looking for
Technology Transfer Specialist

Join “start-up” Biologics division with strong international and local team at site!

 

 
We are waiting just for you!


 
 

What will you do:

  • Generate robust tech transfer plans and protocols in close collaboration with biologics process & analytical development, manufacturing, QC/QA and, if applicable, external partners
  • Provide technical expertise on manufacturing processes during initial risk / gap assessments and make recommendations on risk mitigation actions
  • Generate technical reports to a high standard and coordinate review and approval from key stakeholders.
  • Collect and review process information, data, analytical methods and perform process risk assessments / GAP analysis on processes transferred from internal or external parties
  • Be responsible for the generation of accurate tech transfer plans and protocols in close collaboration with development and production teams
  • Coordinate and execute process risk assessments for scale-up operations and transfer to large scale production.
  • Develop, maintain and continually improve templates for process transfer documentation
  • Participate in continuous improvement of products and risk mediation

What do we expect:

  • Good knowledge of biomanufacturing processes for microbial and mammalian technology
  • Good communication skills both verbal and written; excellent team spirit
  • Action oriented and driving for results with good organizational skills
  • Good problem solving skills, experienced in operations, HSE and technical writing
  • Experience with working under GMP - good knowledge of cGMP and FDA requirements for biologics manufacturing, validation and technology transfer requirements
  • Experience with technology transfer and scale up, working in multidisciplinary teams
  • Experience with disposable and stainless steel equipment desired
  • Fluent English

 

Aplikuj