DP Manufacturing Lead

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.

Apply Now