Manufacturing Scientist at Pharming Group

Purpose of the role:

The manufacturing scientist will support projects that are in late stage development and/or in the commercial phase. The scientist ensures a smooth transfer of the manufacturing process to the commercial production and troubleshooting once the product is commercially available. Due to the growth of the company the product portfolio is changing. Traditionally Pharming’s portfolio was protein based, but recently also a small molecule compound was licensed in and there might be other platforms coming.

Areas of responsibility:

  • To implement and validate Manufacturing related changes (currently only externally at CMOs) in order to develop scientifically sound processes
  • To perform risk assessments of Manufacturing related topics in order to minimize risks and balance efforts
  • To define the strategy of Manufacturing related projects together with other relevant departments at Pharming and CMOs in order to be aligned with Pharming’s strategy
  • To ensure progress of assigned Manufacturing related projects in order to meet the timelines
  • To set up study plans, interpret data and report results in final reports in order to have scientifically sound data to support the filing
  • To be the focal point for CMOs / Suppliers with respect to relevant scientific issues in order to have streamlined communication lines
  • To perform Manufacturing related activities according to the Pharming quality system in order to stay in compliance with cGMP guidelines


Skills:

  • Problem analysis: connects different aspects of information to gain insight, questions (perceived) certainties in order to come up with solutions
  • Decisiveness: makes timely decisions, even if all information is not available, considering the consequences
  • Persuasiveness: makes his/her point and achieves a positive result with a difficult proposition. States the common interest.
  • Adaptability: comfortable to act with minimal direction in a fast-paced environment and able to adjust workload based upon changing priorities 
  • Excellent verbal and technical writing skills both in English and Dutch (French is an advantage), separating main issues from secondary issues and sharing information in a logical order


Knowledge and Experience:


     Knowledge:

  • Bachelor’, Master's degree or PhD e.g. (Chemical) Engineering, Pharmacy, Biochemistry, Life Science & Technology, Biology
  • Sound knowledge and understanding of pharmaceutical development (biologics, small molecules), documentation requirements, systems and equipment 
  • Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)

    Experience:
  • Minimal 4 years of relevant working experience or Master’s degree/PhD with minimal 2 years of relevant working experience

Find out more about drug development at Leiden Bio Science Park.

R&D