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Process Development Specialist

Sartorius -
上海市

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完整职位描述

The Process Development specialist is responsible for acting as an enabler for developing specific process based on internal/external request with our products and technologies, as well as monitoring and improving relevant procedures and activities. This role will make Sartorius the “partner of choice” to the biopharma companies. The holder of this position will develop new process of identified focus modality to support customer’s PD, implant new process from global team to local application, support sales reps in identifying new opportunities and align benefits to create value for key customers. Working as a process development specialist, you'll aim to optimize the performance of existing systems. You'll do this by identifying and developing new processes for product manufacturing, and implementing process controls to ensure the products are of a high quality and produced in a way that can be accurately replicated.

Main Responsibilities & Tasks:

Own the 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 Report and Application Note, Ensure the timely and correct documentation of processes.
Support customer the process transfer, coordinate with AS/Mkt team for promoting the process/AN for better customer awareness and commercial value.
Work closely together with FAS and Product Marketing Specialist across the organization to ensure stable processes for customers.
Secure that Process Development is involved and contributing to the Technology ambitions for the future.
Execute trials and demo activities associated with dedicated processes, including hands-on trials in the lab, as well as by working closely with FAS/BA team; keep ownership over the projects until process is robust.
Support process transfer wherever needed, regionally as well as globally.
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.

Qualifications & Skills:

Master’s degree or above in biotechnology, biochemistry or equivalent in life sciences, preferred Ph.D.
Min. 5 years of working experience in biopharmaceutical process development, scale-up, process characterization, technology transfer, or production
Have 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.
Have sufficient Hands-on skills for new process development.
Excellent skills in communicating and presenting technical added values.
Excellent teamwork skills and proven ability to also 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

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