Sr. Scientist, Pre-clinical & Clinical Assays - United States, United Kingdom, Switzerland
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- We are seeking an experienced and self-motivated Research Scientist to join an exciting, fast growing and well financed new company to develop novel gene editing therapies for serious diseases. This position will report to the Director of Preclinical and Clinical Assays.
- The successful candidate will be someone who is responsible for independently and efficiently managing technological assay and study transfer to CROs and other external vendors.
- This position requires knowledge of GXP-like method qualification and GXP-quality level method validation, and associated documentation in support of regulatory submissions.
- This position also requires a broad and wide ranging experience of designing and monitoring protein, cell and molecular biology and immunology assays in order to manage development and validation at CROs.
- The position also requires a working knowledge of designing and managing animal studies at animal CROs.
- The position requires enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.
- Efficiently design experiments, utilizing a deep and broad knowledge of method development and qualification of protein, immunological, molecular and cellular biology techniques employing phase appropriate strategies at CROs
- Monitor GLP quality level method validation of assays at CROs by providing technical expertise and troubleshooting, as needed, and review of documents for multiple preclinical and clinical projects simultaneously
- Plan, transfer and execution of critical assays, samples and reagents to CROs
- Manage outsourced animal studies at CROs for quality and timeliness
- Analyze and present complex experimental data
- Manage critical project and program deadlines
- Effectively communicate results and project progress, and discuss technical challenges to all appropriate team members
- Manage critical time-lines and resource allocation
- Advanced degree in Molecular Biology/Protein and Cell Biology/Immunology or other relevant fields
- MS with 15 years’ or PhD with 3 years’ experience in Assay Development and Validation in support of preclinical and clinical activities for early and late stage therapeutic programs
- Experience in developing and qualifying molecular biology techniques including, but not limited to, quantitative PCR (qPCR), and DNA Sequencing (NGS) techniques
- Experience in developing and qualifying Protein Biology assays including, such as HPLC, ELISA, MSD
- Experience in developing and qualifying Immunological techniques including Multi-parameter flow cytometry
- Experience in developing and qualifying Cell Biology methods utilizing mammalian cell culture, transfection and cell-based assays
- Prior experience working in a Biotechnology pharmaceutical company coordinating and managing external projects and animal studies at CROs within tight time-lines Excellent oral and written communication skills
- Inter-personal skills: Ability to work independently as well as collaborate with peers and effectively work in a fast-paced and cross-functional results oriented research team environment Ability to work within tight time-lines for successful and timely execution of project and program goals
- Financial management of projects, including on-time and on-budget deliverables
- Ability to travel, if required (Approximately 25-30%)
- Experience working at a CRO managing GXP quality level method validation and sample analysis projects for sponsors
- Experience in authoring and reviewing regulatory documentation for GLP or GCLP quality level projects, for quality and timely delivery
- Experience in managing in vivo animal studies at CROs
- Detailed knowledge of Cellular and Tumor Immunology principles
- Basic knowledge of gene editing and company based technology
- Scientific Rigor/Attention to detail – Maintains high scientific rigor and attention to detail in designing and testing hypotheses and analyzing data. Challenges assumptions, demonstrates highly organized thinking and documentation.
- Trouble-shooting/Problem-solving – Effectively trouble-shoots complex and heterogenous problems with assays and studies at outside vendors to effectively meet project and corporate time-lines and goals.
- Communication and Teamwork – Effectively expresses ideas in written, visual, and oral context. Able to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
- Passion - Creates an exciting environment where there is a true passion for the vision of our company Therapeutics to bring novel medicines to patients suffering from serious diseases.
- Results Orientation / Productive Work Habits – Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns / utilizes resources effectively and efficiently.