Senior Scientist CMC

4 weken geleden

Leiden, Zuid-Holland, Nederland ProQR Therapeutics Voltijd
Job Title: Senior Scientist CMC

Job Summary:

ProQR Therapeutics is a biotechnology company dedicated to developing life-changing RNA therapies. Our Chemistry, Manufacturing and Control (CMC) Department is seeking a highly motivated and experienced Senior Scientist to join our team in Leiden. The successful candidate will be responsible for managing all aspects of drug substance (DS) process development and manufacturing, including cGMP manufacture of clinical batches.

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.

Requirements:

- 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.

About ProQR Therapeutics:

At ProQR Therapeutics, we believe in the value of a diverse and inclusive workforce. 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. We offer a range of benefits, including 8% holiday allowance, 30 vacation days, an annual performance bonus, stock options, a premium-free pension plan, a commuting allowance, and a subsidized staff restaurant.

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