Senior Scientist Process Chemistry

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 Senior Scientist (Full-time) with a passion for chemistry to join our team. 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 and clinical development.

Location: Leiden (on-site)

The Role:

ProQR is looking for experienced and creative individuals to join our Chemistry and Drug Substance (DS) manufacturing team to lead process optimization efforts and supervise/lead tech transfer, and campaign execution to support clinical trials, and regulatory submissions. The person hired will need to be highly motivated and flexible, with the ability to work in a fast-paced environment and provide creative novel solutions to challenging problems.

Responsibilities:

• Lead and/or supervise the design and development of (oligonucleotide) synthesis and purification processes for the manufacture of API using the most modern technologies.
• Demonstrate technical and scientific knowledge in a highly regulated environment with the utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges.
• Provide technical leadership in the scale-up and demonstration of new chemical processes in development and large-scale equipment.
• Collaborate in technology transfer activities to CRO/CMO organizations and the internal ProQR manufacturing team to ensure processes are technically robust, well-developed, well-characterized, and safe.
• Collaborate with cross-functional teams to support project goals and deliver material and information for clinical trials and regulatory submissions.
• Drive continuous improvement initiatives to enhance process efficiency and product quality.
• Plan and lead short-term and long-term development activities, including resource allocation, to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
• Serve as a technical expert and stay current with advancements in oligonucleotide chemistry and related technologies.

Required qualifications:

• PhD degree in organic chemistry or related discipline with a minimum of 4 years of pharmaceutical industry experience

Additional Skills/qualifications

• Biotech/Pharmaceutical industry experience, including demonstrated experience in DS (API) process development and cGMP manufacturing
• Experience with technical transfer of processes into manufacturing operations
• Possess a solid understanding of unit operation design, process modeling, process equipment selection, and scale-up methodologies
• Expertise in oligonucleotide and/or solid-phase chemistry process development with working knowledge of regulatory expectations
• Extensive hands-on expertise in the synthesis and purification of oligonucleotides, and scale-up is preferred
• Solid written and oral communication skills, self-motivation, strong interpersonal skills, and attention to detail are necessary.
• Prior experience in authoring regulatory documents and/or supporting regulatory filings (IND, IMPD) is preferred.
• Track record with the ability to execute multiple concurrent projects within a cross-functional team environment in a fast-paced environment.
• Ability to influence others to promote a positive work environment

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
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, Rebel Café and other social events)

Do you want to be part of our devoted team of enthusiastic professionals? Do you think you can contribute to achieving our mission? Do you want to work in a challenging environment where your work can really make a difference? If so, we’re looking forward to receiving your application by filling out our application form.

You can contact Silvia Catellani via recruitment@proqr.com if you have any questions.