MS&T Senior Process Lead

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicines, offering new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us! www.polpharmabiologics.com

We are looking for:

MS&T Senior Process Lead

 

You will take care of:

  • Establish project plans, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify risks, challenges and propose solutions. Work with Head of MS&T to assess & plan site resource needs & get management approval for resources (FTEs, investments, external costs), strategies & timelines
  • Ensure and supervise the preparation of a Technology Transfer Risk Assessments (Gap Analysis) and work across functional teams to generate a Process Transfer Plan
  • Ensure that all relevant technical information and documentation for transfer to manufacturing and for commencing process validation is available in a timely manner and to a high standard
  • Lead and oversee the generation of required process risk assessments throughout technology transfer and in preparation for process validation
  • Generate required validation masterplan, protocols and reports in collaboration with other functional experts and/or external consultants
  • Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches and engineering batches for transfer
  • Provide input into overall project strategy and plans including timelines
  • Contribute to process improvement and optimization for process transfers
  • Provide technical input into deviation investigations and CAPA implementations
  • Contribute to HA inspection readiness
  • Support creation of Master Batch Record for transfers

 

If you have:

  • Higher education
  • 5 years of experience in a similar position
  • Excellent understanding of bioprocessing technologies for monoclonal antibodies, recombinant proteins from both mammalian and microbial expression systems.
  • Understanding of biosimilar manufacturing would be beneficial.
  • Good understanding of cGMP and process validation requirements and min. 2 years of experience in the field
  • Result driven and action oriented with ability to deliver to tight timelines
  • Good problem solving skills, analytical thinking and ability to understand complex challenges involving multiple stakeholders
  • Excellent team player with strong communication skills, ability to drive and motivate a team
  • Project management experience
  • Good organizational and planning skills
  • Experience with both single use and stainless steel technology
  • Understanding of quality control for biologics and analytical method development would be of benefit
  • Experience with preparation of documents for regulatory filing would be of benefit
  • Fluent English

Join our Team!

 

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more
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Polpharma Biologics S.A.
 

Polpharma Biologics S.A.

MS&T Senior Process Lead

 
Miejsce pracy: Polska, Pomorskie, Gdańsk
 
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Ważna jeszcze 0 dni (do 2019-09-02)
 
 

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