Dp Manufacturing Lead

1 maand geleden

Leiden, Nederland ProQR Therapeutics Voltijd

ProQR Therapeutics is a biotechnology company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, USA. ProQR is focused on the development of life changing RNA therapies to meet the unmet need of individuals and families with common and rare diseases. A team of 150+ enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the communities we serve. Our proprietary Axiomer RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA), which is machinery present in all human cells to repair G-to-A mutations, modulate protein, and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases.

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.

**Location**: Leiden, NL (on-site)

**The Role**:
The DP manufacturing lead will be responsible for oversight of outsourced DP manufacturing activities.
- 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 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

**ProQR as an employer**:
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.

We offer an exciting and innovative working environment in a very committed organization, with the following benefits:

- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, Rebel Café and other social events)

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