Principal Process Engineer

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As a Principal Process Engineer in Pharmaceutical Development, you are part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) and member of the Process Engineering and Manufacturing group 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 aseptic manufacturing process development for parenteral drug products (Synthetic molecules and Biologics) from Phase 1 through Launch. The Pharmaceutical Development Process Engineer ensures robust clinical and commercial process designs for effective process validation and successful commercialization.

As an experienced scientist in the process development and launch of parenterals synthetic molecules (oligonucleotides, peptides and small molecules) , your major responsibilities in this position are the following:

• Development of robust manufacturing processes for parenteral liquid and lyophilized formulations including scale-up, process characterization & validation and transfer to global commercial manufacturing sites.
• Design and hands-on execution of process characterization/process design studies as part of parenteral synthetic molecule drug product process development
• Representation of Pharmaceutical Development as transfer project leader in global CMC teams, functional representative in cross-functional teams and international committees within Roche.
• Collaborate cross-functionally and with manufacturing sites to ensure alignment and successful project execution, act as a single point of contact for DP Process Development.
• Author relevant sections in  global regulatory submissions for Phase 1-3 and international marketing applications

As the successful candidate you hold a Ph.D. or master degree in chemistry, chemical/process engineering or related fields and bring a minimum of 5 years of professional experience (industry) in process development DP manufacturing related fields of parenteral synthetic molecule dosage forms.
  

• Expertise in parenteral process development, technology transfers to commercial sites and regulatory submissions.
• Demonstrated ability to evaluate program risk and submission risk from a drug product process development and manufacturing standpoint.
• Design / Justification of down-scale models incl. process parameters definition and characterization
• Proven track record of DP SM parenteral launch. Combination products experience is a plus.
• Proven experience authoring DP sections of NDA and/or BLA related to molecules designed for parenteral use. 
• Excellent communication skills and collaborative behaviors, with end-to-end and global thinking, as well as excellent stakeholder management skills
• Willingness to travel internationally (up to 20%)

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