MSAT Process Engineer - Commercial support

工作内容

Department: Manufacturing Science, Analytical and Technology (MSAT)

Position Overview: The Manufacturing Science, Analytical and Technology department (MSAT) is vital to our operations, serving as the scientific foundation of the company. This role supports commercial manufacturing, enhances process and method efficiency, and facilitates the technology transfer of new products. Specializing in upstream cell culture, the successful candidate will play a critical role in improving and monitoring processes at the company site and across the broader of the company network. This position may involve a combination of manufacturing-scale and laboratory-scale activities, with occasional contributions to Technology Transfer initiatives.

Key Responsibilities:

• Process optimization and Support: Monitor and support existing manufacturing processes through data analysis, development of scientific/technical study protocols, and reporting. Address significant deviations by conducting thorough investigations and assessing impacts on processes and products.
• Innovation and Improvements: Drive enhancements in process yield and robustness, backing changes with robust data for implementation at the manufacturing level.
• Data analytics and Modeling: Utilize modeling and analytics to support investigations, enhance process monitoring, implement improvements, and expand process knowledge.
• Technology transfer: Aid in the introduction of new drug substance manufacturing processes. Support the transition from development labs to large-scale GMP facilities, including strategy development for process validation and performance qualifications.

Skills and Qualifications:

• Educational Background: PhD or Master’s in Life Sciences

Candidates with a PhD should have a minimum of 3 years’ experience, and those with a Master’s should have at least 5 years’ experience in process development or MSAT-related roles.

• Language Proficiency: Fluency in English is essential due to the international nature of the role
• Technical Expertise: Experience in mammalian cell culture processes at both lab and manufacturing scales. Knowledge of purification processes is an advantage.
• Flexibility: Willingness to engage in both small-scale laboratory studies and large-scale manufacturing operations. Availability for occasional evening and weekend work

• Team Collaboration: Strong team player with the ability to negotiate and compromise across departments and sites.
• Analytical Skills: Excellent analytical skills, problem-solving capabilities, and attention to detail. Experience with statistical and data trending tools such as JMP, Statistica, Matlab, or Simca is beneficial.
• Regulatory Knowledge: A GMP mindset with familiarity with current Good Manufacturing Practices preferred.