Senior Scientist CMC
Senior Scientist CMC
ProQR Therapeutics
Leiden, Netherlands
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.
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.
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.
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