Scientist/Senior Scientist Gene Therapies – Roche, Gene Therapies in Pharmaceutical Development, Switzerland, Basel-City, Basel.
Scientist/Senior Scientist Gene Therapies in Pharmaceutical Development
About the organization
Roche is leading the industry with respect to the investment in R&D. We drive one of the largest and most promising pipelines.
Pharma Technical Development (PTD) engages with all R&D engines within the Roche group and supports more than 100 development projects with CMC (Chemistry, Manufacturing and Controls) activities.
Pharma Technical Development Europe Biologics (PTDE) brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing processes (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. Our daily work also includes compiling regulatory documents and the transfer of development projects to commercial manufacturing.
We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and “getting it done” mentality. The benefit for the patient is in the centre of our thoughts and efforts. To achieve this goal we have embraced new ways of working and thinking.
The department of Pharmaceutical Development & Supplies is responsible for the development of parenteral drug products from Phase 1 up to Launch. Activities encompass formulation and manufacturing process development for parenteral drug products for all clinical stages and the market, the transfer of product and process to commercial manufacturing sites, commercial product support, line extension development, primary packaging development and drug product supplies for preclinical and clinical studies (Phases 1-3).
As a Scientist/Senior Scientist Gene Therapies, you will oversee drug product activities related to Gene therapies in Pharmaceutical Development and Supplies. Your responsibilities will be as follows:
- Oversee and coordinate Pharmaceutical development of AAV, lentivirus and other related gene therapy parenteral formulations for clinical development and market application
- Development of robust manufacturing processes for Gene therapy drug product, including scale-up, process characterization & validation and transfer to global commercial manufacturing sites
- Representation of Pharmaceutical Development as a pharmaceutical project leader in global CMC teams, a functional representative in cross-functional teams and international committees within Roche, especially those related to Gene therapies
- Provide input to global regulatory submissions for Phase 1-3 and marketing applications (IMA/MAA)
- Be a catalyst in creating an environment of innovation, learning and growth in the field of pharmaceutical development for gene therapies
- Drive a culture of innovation, scientific strength and technical rigour within Pharmaceutical Development teams in the area of Gene therapy
- Provide technical and strategic leadership to project teams, junior staff, and the broader Pharm Dev organization
- Drive strategic thinking on drug product and novel therapeutic development teams by providing knowledgeable input on pharmaceutical development of gene therapies
Who you are:
Education and Professional Background
- Masters or PhD degree in chemistry, biology, biochemistry, pharmaceutics, chemical engineering or related field
- Several years (at least 5-8 years) of experience in the pharmaceutical industry, combined with strong technical knowledge and special expertise in gene therapies
- Experience of taking a gene therapy medicinal product through clinical phases up to market application is a plus
- Development of fill-finish, combination product assembly, gene therapy, and/or associated manufacturing processes
- Tech transfer experience or experience in organizing and leading cross-functional teams is a plus
- A high degree of self-motivation, scientific strength and technical rigour is required
- Experience of working with third parties is an advantage
- Proven track record of technical accomplishments in the gene therapy field
- Ability to build and lead cross-functional matrix teams providing clear prioritization of project goals and enabling collaborative decision making in the team
- Excellent verbal and written communication skills with success in building trustful relationships and influencing others in cross-functional areas
- Ability to simply and clearly articulate deliverables to the technical and non-technical audience across the organization
- Strong interest to embrace new ways of working and to act as a change agent
- Proven ability to work proactively and think strategically, including assessment of the business impact of technical decisions
- Proven ability to work with senior management and to effectively partner and influence stakeholders and partners
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Roche is an equal opportunity employer.Research & Development, Research & Development > Research
- Who we are Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.
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Scientist/Senior Scientist Gene Therapies – Roche
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