Vp Head Cmc

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.

We are currently looking for an experienced **VP, Head of Chemistry, Manufacturing & Control** (full-time) to join our team.

**Location**: Leiden, NL

**The CMC Department**:
The Chemistry, Manufacturing and Control (CMC) Department has a central role within the ProQR Therapeutics organization. The CMC Department develops, manufactures and characterizes oligonucleotides and therapeutic formulations for pre-clinical and clinical phase development. We have several programs in early-stage development as part of our Axiomer RNA editing platform. Our way of working involves a combined approach of in-house high throughput manufacture and small-scale early development in newly refurbished laboratories and outsourced development, ‘scale up’ and GxP activities.

**The role**:
We are looking for an experienced professional in Chemistry, Manufacturing & Control to lead the CMC department. The Head of CMC has developed products from Discovery through to late phase clinical studies, with a diverse background in CMC, drug development and supply chain. In addition, the Head of CMC has a strong background in people management and brings a network in the CMC space.

The Head of CMC is ultimately accountable for the on-time delivery of investigational product supplies. In addition, the head of CMC is accountable for the CMC content of the regulatory dossier and subsequent authority interactions. The span of control of the Head of CMC ranges from pre-clinical, Phase I, Phase II/ Phase III.

The Head of CMC is part of the company's leadership team.

**Tasks and key duties**:

- Accountable for developing and executing the Chemistry, Manufacturing & Control strategy for pipeline products.
- Accountable for the budget and financial performance of the CMC department
- As a member of the Leadership Team contribute to the development of corporate goals and take accountability for delivery.
- Responsible for overseeing and enabling activities to ensure the efficiency and effectiveness of the CMC department and ProQR as a whole, utilizing data trending and risk management tools.
- Identify and analyze high-impact, complex and cross-functional business issues and gaps. Make sure continuous improvement of processes is embedded in the organization. Embed an environment of innovation and cultivate new (scientific) insights.
- Responsible for hiring, promotions, pay adjustments, performance appraisals. Recruiting and developing a high-performance team. Develop individual team members’ hard and soft skills (challenge, motivate, reward), using individual development plans. Drive development of intellectual capital and continuous education and capability building. Act as a mentor for teams and individuals.
- Responsible for acting across disciplines with senior leaders and external parties to drive and align strategic and operational activities. Responsible for alignment of functional execution plans with approved corporate plans.
- Continuously monitor progress, costs, resource allocations, timelines and develop corrective actions if deviations occur.
- Communicate effectively across work groups, departments and with MT.

**We expect our Head of CMC to be/have**:

- Independent thinker with demonstrated ability to take the lead
- A deliverable-oriented mindset, with a strong sense of ownership
- An advanced degree in biochemical engineering, pharmaceutical chemistry, biochemistry, or relevant technical discipline, coupled with 15+ years of relevant pharma and/or biotech experience
- Experience in development of early and late-stage manufacturing, process validation and clinical supply chain management
- Proven track record in cGMP manufacturing and IND, CTA and NDA/MAA filings; thorough knowledge of relevant FDA and EMEA regulations
- Experience in working with sterile drug products and oligonucleotides is a bonus
- Experience in developing products for rare diseases
- Experience in overseeing outsourced manufacturing models
- Track record in building working