Senior Scientist AD/QC
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 160 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 a Senior Scientist (full-time) to join our Analytical Development and Quality Control (AD/QC) team.
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 two 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 experienced in CMC projects to support the AD/QC 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 Senior Scientist is able to lead projects and assist in regulatory writing for our drug substances and drug products.
The Senior Scientist will report to the Head of AD/QC and will support SMEs in other functional areas. The Senior Scientist will work closely together with CROs and CMOs and takes care of Quality Control activities.
- initiate ideas to improve the support and efficiency of the analytical method development/validation/transfer activities for the ProQR oligonucleotide technology platform
- independently lead multiple assigned projects: establish priorities, checkpoints, and time frames in line with the project and team objectives/deliverables
- writing and review of regulatory filings documentation (CTA/IND, NDA/MAA)
- writing and review of method validation protocols, development reports, and stability study designs
- maintain knowledge of Good Manufacturing Practices (GMP) and guidelines (ICH, Pharm.Eur, USP)
- management of external suppliers (CMO, CRO)
- act as a coach for junior staff members
Location: Leiden, NL
We expect our Senior Scientist Analytical Development and Quality Control 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 early and late stage development manufacturing, process validation and product launch
- experience in regulatory filings documentation (is required)
- knowledge of CMC guidelines applicable in Europe and USA
- 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 :-)
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 are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
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
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
You can contact Yessica de Brouwer via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.