DP Manufacturing Lead

ProQR Therapeutics

Leiden, Netherlands

Our Chemistry, Manufacturing and Control (CMC) Department is currently looking for a DP Manufacturing Lead (Full-time) with a passion for sterile drug product development to join our team in Leiden. The CMC department has a central role within the ProQR Therapeutics organization and is responsible for developing, manufacturing, and characterizing oligonucleotides and therapeutic formulations for research, clinical development and commercialization.

The Role:

The DP manufacturing lead will be responsible for oversight of outsourced DP manufacturing activities.

The successful candidate is enthusiastic about sterile product development and will work closely with other experts/researchers/scientists in an interdisciplinary team environment to progress activities related to the production of oligonucleotides which includes:

  • Accountable for the planning of activities related to drug product manufacturing (together with CMOs) and delivery to meet project milestones
  • Managing outsourced process development/implementation activities, and setting up the control strategies
  • Day-to-day management of CMOs involved in sterile drug manufacturing and packaging
  • As part of interdisciplinary team, providing input to product development experiments
  • Coordinating relevant GMP and technical documentation: review of relevant records with respect to technical details and GMP requirements
  • Providing technical input to the regulatory documents (dossier)
  • Preparation, or revision, of standard operating procedures (SOPs)
  • Identification and implementation of continuous improvement opportunities

We expect our DP manufacturing lead to have:

  • a PhD degree (preferred) and at least 4 years of work experience in Pharmaceutical/Biotechnology Industry or at least 8 years of work in a relevant field in industry (sterile drug product development and manufacturing)
  • Experience of working with external CMOs
  • Knowledge of GMP practices and pharmacopeial methods
  • Experience with sterile, liquid drug product formulation and manufacturing (various dosage forms: vials, prefilled syringes, cartridges)
  • Experience in preparation of CMC regulatory documents for submission in support of clinical trials and MAA application
  • Experience with review of batch manufacturing and packaging records
  • Responsible with a proactive attitude who can work independently
  • Effective verbal and written communication skills in English;
  • Being flexible, analytical, and well-organized

Preferred:

  • Experience with oligonucleotides is a plus
  • Experience with combination products is a plus
  • Experience with QbD is a plus
  • A good understanding of business values and project management
  • Knowledge of GDP and clinical supply principles

Skills and competencies that are required for making the difference:

  • Team player with hands-on mentality
  • Patient-oriented attitude
  • Being able to work in a fast pace environment
  • Strong project planning and management skills, able to prioritize multiple tasks
  • Being a nice person

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