Downstream Processing (DSP) Manager at Pharming Group

About Pharming
Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is small (approx. 220 employees, based internationally) and growing quickly. As a result of this growth we are currently looking for a Downstream Processing (DSP) Manager to join our team in Brabant

About the role:
Pharming is a growing company and one of the capital projects to support this growth is to build our own Downstream Processing Facility (DSP facility). As Manager Downstream Processing you will be a key member of the team that is responsible for the construction and startup of this facility. During the construction and qualification phase the Manufacturing team will gradually expand (expectation 25-30 people) which in the future will run the day to day operations in a commercial pharmaceutical cGMP environment of Pharming’s state-of-the-art manufacturing facility.

 

Areas of responsibilities:

  • To define the Operations needs in the Build & Design project team for the new facility and act as counterpart for the engineers designing the new facility as future Operations Owner
  • To ensure that Lean Manufacturing principles are used to develop the facility
  • To develop all necessary procedures (quality and safety) and master batch records to be used in routine manufacturing
  • To ensure integration with the global ERP system that is being selected
  • To communicate and negotiate with vendors in order to have a facility that can be operated smoothly and is ready for operation in time
  • To build over the years a high performing team and develop necessary training for the staff in order to run the facility smoothly once construction is complete 


Required skills & qualifications in order to be successful in this role:

  • Ability to build an organization from scratch and create a high performing team
  • 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
  • Hands-on-mentality during the construction phase
     

Knowledge:

  • Bachelor’ or Master's degree e.g. (Chemical) Engineering, Pharmacy, Biochemistry, Life Science & Technology, Biology
  • Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)
  • Knowledge of electronic quality systems and ERP systems is an advantage. 
  • Knowledge of tech transfers is an advantage


Experience:

  • Minimal 7 years of relevant working experience 
  • A minimum of 7 years of cGMP production experience in a Downstream Processing facility; experience as project team member in the design phase of a new facility is an advantage as well as managerial experience
  • Experience with lean manufacturing principles (Green Belt certified is an advantage)
  • Experience with regulatory inspections is an advantage

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