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
Who you are
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%)
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
