Process Development Specialist

About the Role

The Process Development Specialist acts as an enabler for developing specific processes based on internal and external requests, applying Sartorius technologies for biopharma customers. This role focuses on accelerating molecule development, transferring processes from global to local application, and improving procedures to deliver high-quality, replicable manufacturing processes.

What You'll Do

• Own designated project of new process development and execution.
• Execute process development activities in the lab for on-time launch of designated projects.
• Provide PD/PC/Scale-up/down/Regulatory consultancy to accelerate the molecule development lifecycle and support locking in long-term business on a modality-relevant basis.
• Create timely and detailed New Process Reports and Application Notes; ensure timely and correct documentation of processes.
• Support customer process transfer, coordinate with AS/Marketing team for promoting the process/AN for better customer awareness and commercial value.
• Work closely with FAS and Product Marketing Specialist across the organization to ensure stable processes for customers.
• Ensure Process Development is involved and contributing to Technology ambitions for the future; secure ownership until processes are robust.
• Execute trials and demo activities associated with dedicated processes, including hands-on trials in the lab, and by working closely with FAS/BA team; keep ownership over the projects until process is robust.
• Support process transfer regionally as well as globally wherever needed.
• Transfer knowledge and best practices to sales team/AS team.
• Act as a process consultant for critical leads/opportunities to drive the adoption of Sartorius technologies/platforms.
• As needed, support regulatory/process related activities to enhance market awareness and the Company’s, the Team’s as well as individual expert image.
• What We're Looking For
• Master’s degree or above in biotechnology, biochemistry or equivalent in life sciences; PhD preferred.
• Min. 5 years of working experience in biopharmaceutical process development, scale-up, process characterization, technology transfer, or production.
• Broad theoretical knowledge in process development, pilot and production scales complemented with in-depth and practical experience in process development.
• Proven skills of relevant process unit operations in cGMP Bioprocessing with related regulatory knowledge.
• Broad (investigational) new drug application and process development knowledge based on proven practical experience.
• Hands-on skills for new process development.
• Excellent skills in communicating and presenting technical added values.
• Excellent teamwork skills and proven ability to work with cross-functional teams without formal authority; takes strong ownership over projects, yet can execute collaboratively.
• Good communication and presentation skills in both Mandarin and English.
• Nice to Have
• PhD preferred.
• Compensation & Benefits
• Salary not disclosed in the job posting.