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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