Handl Therapeutics is looking for a Senior CMC Scientist.
The Senior CMC Scientist will support drug manufacture and supply activities in backing both pre-clinical and clinical development programmes. The role will focus on scientifically supporting and optimising the CMC strategy and overlooking the preparation of the CMC sections of regulatory dossiers. The lion share of the activities will be delivered through CDMOs, the Senior CMC Scientist will be support the selection, auditing and management of these organisations, ensuring a supply of drug substance and drug product which is on time, on budget and to the appropriate quality standards. In addition, the Senior CMC Scientist will oversee the execution of quality assurance and control, materials and logistics and supports the production from early stage product development to full-on market manufacturing.
This new position will report to the Head of CMC.
The Senior CMC Scientist will support that all manufacturing and supply chain processes are robust and scalable for the development and commercialisation of Handl Therapeutics’ gene therapy products. This means:
- Support the implementation of the Process Development, Manufacturing and Supply Chain strategy for Handl Therapeutics: Translates strategies into CMC operational plans
- Build project timelines and manage the critical path, develop CMC project budgets and budget forecasts
- Develop and analyze scenarios, risk assessment and mitigation planning
- Review processes and capabilities for both vector manufacture and cell transfection / production with a view to ensuring that they meet the needs of the business and comply with relevant regulatory requirements
- Support the preparation and implementation of the tech transfer of current manufacturing processes to a GMP / commercial environment
- Execute on-site review of contract manufacturing / third party activities, identify early potential issues and contribute to technical/scientifical solutions to ensure smooth progress of the company’s development and manufacturing activities
- Use expertise in upstream process, downstream process, analytics and other aspects of CMC to inform project decisions
- Participate in GMP audits of suppliers and manufacturers as required to ensure Handl Therapeutics’ interests are considered
- As member of project teams, be responsible for identifying issues and managing the production process to ensure that they are resolved, including managing the related third-party CMC issues
- Prepare CMC regulatory documentation; collect/prepare/write manufacturing sections of regulatory submissions; support leadership with respect to CMC-related discussions with regulatory authorities
- Serve as subject matter expert (SME) with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management: Collaborate cross functionally with internal and external stakeholders such as Discovery, Regulatory Affairs, Toxicology, Medical / Clinical and Quality
- Supports monthly, quarterly and major financial budget cycles
- Prior experience in the gene therapy area, or alternatively experience in the development of other AAV or lentiviral derived products
- Proven ability to interpret experimental results to form appropriate recommendations and provide guidance on next experiments
- Clearly understands GMP and related regulatory requirements; can implement where necessary
- Excellent command of all relevant tools and sources of information in the field of Drug Product Development
- Experience in technical transfers, qualification, validation, trouble shooting, BLA’s, FDA inspections, process scale-up, and commercial operations support
- Experience with managing contract manufacturing organisations and be familiar with international supply chain architectures including vendor selection, qualification, and contracting including the understanding of the inbound quality control for materials and components
- Experience with scientific report writing
- Excellent communication skills, strong organizational skills, the ability to multitask and effective interpersonal skills are required
- Experience in Project Management is a strong plus
- PhD or equivalent in a scientific discipline, or/and at least 3 years of relevant experience in the pharmaceutical industry and drug development is essential, ideally with experience in Adenoviruses as a gene delivery vector or more broadly bring a virology background
- You will part of a team that will change the treatment paradigms of large CNS diseases
- You will work in a challenging and innovative environment where ownership and team playing are highly important for reaching success
- Competitive remuneration package
Contact Barbara Christiaens at +32 497 52 63 88.