Scientist/Senior Scientist Pharmaceutical and Processing Development (temporary position for three years)
Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
"Global Technical Development" (PTD) actively collaborates and develops innovative technical solutions to efficiently transform scientific ideas into products. The mandate of the group is, to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, collaboration, dedication, and mutual respect and contributes every single day, continuously improving what it does.
“Europe Biologics“ (PTDE) supports biologics from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.
As a Scientist in Formulation and Processing Development, you are part of the Department “Pharmaceutical Development and Supplies” in Pharma Technical Development (PTD) in Basel, Switzerland. The department 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).
Your major responsibilities in this position are the following:
Pharmaceutical development of biologics, peptides and small molecules, cell and gene therapy parenteral formulations for clinical development and market (including line extensions)
Development of robust manufacturing processes for parenteral liquid and lyophilized formulations for biologics, peptides and small molecules, including scale-up, process characterization & validation and transfer to global commercial manufacturing sites
Representation of Pharmaceutical Development as pharmaceutical project leader in global CMC teams, functional representative in cross-functional teams and international committees within Roche
Provide input to global regulatory submissions for Phase 1-3 and the market (BLA/MAA/NDA)
Evaluation and implementation of new methods and technologies, scientific contributions (e.g. publications and conference talks), supervision of research projects and initiation of new research activities
Contribute to the organizational development of Pharmaceutical and Processing Development Parenterals
As the successful candidate you hold a Ph.D. in pharmaceutical sciences, chemistry, biochemistry, biotechnology, or related fields and bring a minimum of 3-6 years of professional experience (industry) in formulation development of biologics, protein analytics and/or process development of parenteral dosage forms for biologics, peptides and small molecules parenterals.
Experience in relevant technologies and processes (e.g. aseptic manufacturing, biochemical and biophysical analytical techniques, lyophilization, drug delivery)
Excellent team and communication skills with proven organizational and planning abilities as well as excellent stakeholder management skills
Automation knowledge and hands-on experience in lab automation, robotics and high throughput applications including working with liquid handling stations, HTS analytics and advanced data handling and processing is a plus
In depth knowledge or experience in digital tools, ELN, data analytics is a plus
Excellent command of English
Excellent IT knowledge. Ability to use data analysis and visualization software systems such as Modde, JMP, Matlab, LabView. Experience in automation software and/or database systems would be a plus
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