Process Development Specialist

Reposted 2 Days Ago
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Shanghai, Shanghai Municipality, Shanghai, CHN
In-Office
Senior level
Biotech
The Role
Lead and execute process development projects for biopharma products, performing lab trials, scale-up/scale-down and process characterization. Produce documentation (New Process Reports, Application Notes), support technology transfer and regulatory activities, collaborate with sales and cross-functional teams to drive adoption and customer value, and ensure robust, reproducible manufacturing processes.
Summary Generated by Built In
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

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers

Skills Required

  • Master's degree or above in biotechnology, biochemistry or equivalent in life sciences
  • Ph.D. in relevant discipline
  • Minimum 5 years' experience in biopharmaceutical process development, scale-up, process characterization, technology transfer, or production
  • Broad theoretical and practical knowledge in process development across pilot and production scales
  • Proven skills in relevant process unit operations in cGMP bioprocessing with related regulatory knowledge
  • Practical hands-on skills for new process development and execution of lab trials
  • Experience with process transfer and technology transfer activities (regional and global)
  • Excellent communication and presentation skills (technical) in Mandarin and English
  • Proven ability to work collaboratively with cross-functional teams and take ownership of projects

Sartorius Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sartorius and has not been reviewed or approved by Sartorius.

  • Healthcare Strength Health coverage includes multiple medical plan options with dental, vision, HSA/FSA, EAP, and wellness resources across many locations. Quality of core medical, dental, and vision is characterized as solid.
  • Retirement Support Retirement offerings include a 401(k) with a company match highlighted in U.S. materials and employer‑verified listings. The match is characterized as generous at some sites.
  • Flexible Benefits Flexible hours and hybrid/home‑office options are available where roles and regions allow, with role‑dependent perks in some locations. Broader extras such as commuter benefits, discounts, and tuition assistance add optionality where eligible.

Sartorius Insights

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The Company
HQ: Göttingen
9,059 Employees
Year Founded: 1870

What We Do

Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing. We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide. With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies. In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe. Join our team, partner or collaborate with us.

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