Senior Scientist Process Chemistry

Senior Scientist Process Chemistry

ProQR Therapeutics

Leiden, Netherlands

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

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