Associate Director Late Stage Development AD/QC at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 140 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 patients we serve.
Our CMC department is currently looking for an Associate Director Late Stage Development AD/QC (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 clinical development and commercialization. We have many programs in early stage development and one in late stage development. Our way of working involves a combined approach of in house and outsourced activities. The AD/QC team is part of the CMC organization.
We are looking for a Subject-Matter-Expert in Late Stage CMC-Analytics to support the Analytical Development & Quality Control team. We are looking for a hands-on professional that has extensive knowledge of regulatory and quality requirements supportive to method validation, registration stability and the regulatory filing process. The Associate Director Late Stage Development AD/QC has high affinity with the implementation of structure and process improvement, preparing the team for expansion in late stage development.
The Associate Director Late Stage Development AD/QC will report to the Head of AD/QC and will support SMEs in other functional areas in a matrix structure (CMC Program Management, Process Development, Formulation Development, Manufacturing, Clinical Supplies).
- initiate ideas to improve the support and efficiency of the analytical method development/validation/transfer activities for the oligonucleotide technology platform
- independently lead multiple assigned projects: establish priorities, checkpoints, and time frames in line with the project and team objectives/deliverables
- advise and inform management and stakeholders about potential AD/QC challenges and risks, prioritization or resources conflicts and make suggestions to resolve or mitigate these
- writing and review of method validation protocols, reports, stability study designs, and regulatory filings documentation (CTA/IND, NDA/MAA)
- maintain knowledge of Good Manufacturing Practices (GMP) and (ICH) Guidelines
- management of external suppliers (CMO, CRO)
- act as a coach for junior staff members
In addition, the Associate Director Late Stage Development AD/QC will bring structure to the group enabling scale up and absorption of late stage activities.
We expect our Associate Director Late Stage Development AD/QC to have:
- an advanced degree (PhD/MSc/Engineer; or appropriate Master’s level) preferably in Chemistry, Pharmaceutical Sciences or Life Sciences
- at least 5-10 years of working experience within the Biotech / Pharmaceutical industry
- experience in quality control during late stage development manufacturing, process validation and product launch
- knowledge of CMC guidelines applicable in Europe and USA
- affinity with business analytics, KPIs & visualization solutions
- experience in or affinity with the field of (ultra)orphan products is a pre.
Skills and competencies that are required for making the difference:
- Analytical and accurate, well-organized
- Long term thinker
- Flexible and able to deal with change
- Hands-on mentality
- Pro-active attitude
- Autonomous and coachable
- Being able to work in a fast pace environment, having strong project planning and management skills, being able to prioritize multiple tasks
- Critical thinking, decision making and problem-solving skills
- Excellent communication skills
- Excellent knowledge of spoken and written English
- A nice person :-)
We offer an exciting and innovative working environment in a very committed organization, with competitive benefits, including an annual performance bonus, stock options and flexible working arrangements. The salary and terms of employment will be discussed in detail at an appropriate stage of company interview.
In hiring new ProQRians, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture.
Please apply as soon as possible if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.