DP Manufacturing Lead

1 maand geleden


Leiden, Zuid-Holland, Nederland ProQR Therapeutics Voltijd

Job Title: DP Manufacturing Lead (Pharmaceutical Industry Expert)

Department: Chemistry, Manufacturing and Control (CMC)

Location: Leiden, Netherlands

We are seeking a highly skilled and experienced DP Manufacturing Lead to join our team at ProQR Therapeutics. As a key member of our CMC department, you will be responsible for overseeing outsourced DP manufacturing activities and working closely with our interdisciplinary team to progress activities related to the production of oligonucleotides.

Key Responsibilities:

  • Accountable for the planning of activities related to drug product manufacturing and delivery to meet project milestones
  • Managing outsourced process development/implementation activities and setting up control strategies
  • Day-to-day management of CMOs involved in sterile drug manufacturing and packaging
  • Providing input to product development experiments
  • Coordinating relevant GMP and technical documentation
  • Providing technical input to regulatory documents
  • Preparation or revision of standard operating procedures
  • Identification and implementation of continuous improvement opportunities

Requirements:

  • PhD degree in a relevant field (preferred) and at least 4 years of work experience in the pharmaceutical industry or at least 8 years of work experience 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)
  • Experience in preparation of CMC regulatory documents for submission
  • Experience with review of batch manufacturing and packaging records

Preferred Qualifications:

  • Experience with oligonucleotides
  • Experience with combination products
  • Experience with QbD
  • Good understanding of business values and project management
  • Knowledge of GDP and clinical supply principles

What We Offer:

  • 8% holiday allowance
  • 30 vacation days
  • Annual performance bonus
  • Stock options
  • Premium-free pension plan
  • Commuting allowance
  • Subsidized staff restaurant
  • Unlimited (un)healthy snacks and drinks
  • Employee events

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