- To engage in hands-on laboratory work within the cell culture process development team to facilitate the creation of adaptable processes suitable for technology transfer to the cGMP manufacturing teams. Developing an understanding of cGMP manufacturing facility limitations and their impact on development operations.
- To contribute to Process Validation/Process Characterization initiatives by conducting and/or supporting laboratory-scale studies, incorporating QbD principles and DoE methodologies.
- Data analysis and interpretation to determine critical process parameters and operational ranges under supervision. Utilization of statistical software for Process Validation/Characterization tasks.
- Acting as a cell culture Subject Matter Expert, aiding the lead scientist in process risk assessment such as Failure Mode and Effects Analysis (FMEA).
- Delivering high-quality communication to ensure exceptional customer experiences through written documentation, technical justifications, teleconferences, and face-to-face meetings. Collaborating as part of a site and global project team, managing multiple projects and ensuring timely completion of project milestones. Hands-on cell culture activities encompass scale-down model validation, primary harvest, process parameter screening, NOR and PAR identification, defining control strategies using various equipment such as shake flasks, bench-scale bioreactors (10L), depth filters, and robotic bioreactor systems (Ambr250).
- Adhering to the highest scientific standards under the leadership of the Line Manager.
- Providing project updates to internal and external stakeholders.
- Contributing to departmental efficiency and safety programs as necessary.
- Depending on project scope, overseeing project teams may be required.
- Occasional weekend work may be needed for this role.
- Degree/PhD in a relevant Scientific field or Equivalent qualification.
- Minimum of 5 years' relevant work experience or PhD with 2 years of postdoctoral experience.
- The final role provided will be based on the candidate's experience.
- Proficient in the theory and application of mammalian cell culture.
- Practical laboratory experience in operating robotic bioreactor systems is highly advantageous. Knowledge of cGMP regulations is a plus.
- Prior experience with statistical software or strong statistical knowledge is beneficial.
- Previous exposure to facility fit assessment, process risk assessment, or strong QbD knowledge is advantageous. Good problem-solving and analytical skills. Strong communication skills (verbal and written).
- Excellent technical writing skills and a team player.
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1 alternative title for "Senior Scientist, Cell Culture Development" using "en-US" language - Singapur, Singapore - Lonza
Description
Today, Lonza is globally recognized in life sciences with operations across three continents. In our line of work, there is no secret recipe for success. Our most powerful solution is our team of skilled individuals collaborating to generate innovative ideas that drive business growth while benefiting society. In return, we empower our employees to steer their own career paths. Their inventive contributions, whether big or small, have a genuine impact on the world. This is the kind of impactful work that defines us.
Were you aware that we hold the prestigious title of being the inaugural biologics contract manufacturer in the industry?
We provide a platform for exposure to cutting-edge biotechnology advancements and established pharmaceutical firms, offering insight into the manufacturing technologies essential for producing future mammalian treatments and cell therapies. Our global manufacturing network is renowned for its dependable, high-quality services, regulatory compliance, global presence, innovative technology platforms, and extensive expertise. We take pride in our role as a part of this esteemed global network, directly from our base in Singapore.
The selected candidate for this role will be part of the Cell Culture Development team at Lonza Singapore. This team focuses on developing and characterizing manufacturing processes employed in producing novel therapeutic recombinant proteins for Lonza's diverse client base worldwide. The primary objective of this position is to assist the lead scientist in process development and characterization activities (BLA studies), providing technical expertise to address troubleshooting tasks at both laboratory and manufacturing scales.
Key Responsibilities:
Key Requirements:
Every day, Lonza's products and services positively impact millions of lives. For us, this responsibility is both rewarding and vital. How we attain our business goals is just as crucial as the accomplishments themselves. At Lonza, we prioritize the well-being of our employees and the environment. Any success we achieve is meaningless if not obtained with integrity.
Individuals are drawn to Lonza for the intellectual challenge and creative opportunities in solving complex problems and innovating in life sciences. In return, we offer the gratification of knowing that our work enhances lives worldwide, making a substantial difference.
Reference: R59444