Job Detail

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 of 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 center of our thoughts and efforts. To achieve this goal we have embraced new ways of working and thinking.

As a Senior Scientist in Formulation and Process Development, you are part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) in Basel, Switzerland. The department Pharmaceutical Development 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 and line extension development.

Your major responsibilities in this position are the following:

• Process development and Technical Transfer 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.


• Work closely with the commercial manufacturing network and conduct studies, risk assessments, pilot runs and process performance qualification runs to generate data and support transfer and launch of biologic parenterals


• Representation of Pharmaceutical Development as pharmaceutical project leader in global CMC teams, functional representative in cross-functional teams and international committees within Roche.


• Authoring, reviewing and providing 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.


• Contribution to the organizational development of Pharmaceutical Development PTD Biologics Europe.

Your Qualification:

As the successful candidate, you hold a Ph.D. with a minimum of 4-6 years or a Masters with 6-10 years of professional experience (industry) in pharmaceutical sciences, chemistry, chemical/process engineering, biochemistry, biotechnology, or related fields in process development of parenteral dosage forms for biologics, peptides and small molecules parenterals.

• Proven experience in aseptic process development for parenterals, including design of down-scale models, process parameters definition and characterization (e.g. for new technologies), process validation and transfer as well as quality by design principles is desired.


• In depth knowledge and experience with F/T, mixing and filling technologies and platforms both conventional and single use platforms.


• Experience in late stage development and the commercial manufacture of drug product is preferred.


• Proven experience with Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and manufacturing process


• Proven experience in aseptic DP manufacturing of sterile drug product both in liquid and lyophilized forms is desired.


• Experience and demonstrated knowledge in drug product facility design, environmental controls and maintenance for the manufacture of sterile drug product.


• Good knowledge of FDA/ICH/EMA guidelines and cGMPs, phase-appropriate development strategies and global requirements for IND, NDA and BLA submissions (or their regional equivalents) is required.


• Experience with IND/BLA/MAA writing and/or review is required.


• Excellent communication skills and collaborative behaviors, with end-to-end and global thinking, proven organizational and planning abilities as well as excellent stakeholder management skills


• 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 JMP, Matlab, LabView.

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