Senior Scientist CMC

at  ProQR Therapeutics

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 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 and clinical development.

REQUIRED QUALIFICATIONS:

• PhD degree in organic chemistry or related discipline with a minimum of 4 years of pharmaceutical industry experience
• Experience working in pharmaceutical industry with expertise in oligonucleotide and/or solid-phase chemistry process development and (cGMP) manufacturing with working knowledge of regulatory expectations
• Extensive hands-on expertise in the synthesis and purification of oligonucleotides, and scale-up is preferred
• Track record with the ability to execute multiple concurrent projects within a cross-functional team environment.
• 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.
• Ability to multi-task and work in a fast-paced environment.

PROQR AS AN EMPLOYER

As an employer, we are a true believer in 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 ensuring 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 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
• 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

THE ROLE:

ProQR is seeking a talented Process Development Senior Scientist to join our Chemistry and Drug Substance (DS) manufacturing group within the CMC department. The group is responsible for the development and implementation of drug substance manufacturing processes and technologies to advance ProQR’s portfolio of Axiomer RNA editing oligonucleotides.
The successful candidate will be a highly motivated and team-oriented individual with a strong background in organic chemistry, preferably in oligonucleotide chemistry, and experience in pharmaceutical development. The Senior Scientist is a senior leader accountable for managing all aspects of drug substance (DS) process development and manufacturing, including cGMP manufacture of clinical batches. A strong knowledge of large scale solid-phase chemistry, purification techniques, and analytical methods is required, as well as a working knowledge of cGMP and FDA/EMA guidelines. The Senior Scientist will be responsible for authoring regulatory sections (IND, IMPD, and/or CTA) related to DS manufacture and will lead tech transfer and scale-up activities for the DS manufacture of Axiomer programs.

KEY RESPONSIBILITIES:

• Coordinate and manage collaborations and CRO/CMO operations to ensure deliverables meet project needs.
• Coordinate and manage DS process development and (cGMP) manufacturing, both internally and at CMOs, for one or more ProQR Axiomer programs.
• Manage technology transfer from our internal manufacturing facilities to contract manufacturers (CMOs) or between CMOs
• Work cross-functionally to deliver regulatory documents and support regulatory filings
• Serve as a technical expert and keep current in the field of organic and process chemistry with a focus on oligonucleotide manufacturing
• Advance enabling technologies to accelerate pharmaceutical development and to improve process efficiency
• Contribute to CMC and drug substance development teams by providing experimental results, technical updates, documentation, data interpretation, recommendations, etc.
• Prepare RFPs and technical packages for GMP manufacturing campaigns.
• Work with QA and QC on drug substance specifications and provide guidance for audits.
• Expedite research and manufacturing timelines and support in developing appropriate risk mitigation strategies to guarantee DS supply
• Supervise and mentor junior staff.