Tsms Scientist

Description:

The successful candidate will be required to provide technical expertise in the area of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities.

Responsibilities:

• Understand the purpose and science of the process; have an in-depth knowledge of the science (including analytical) behind the molecule and the process. Expert in buffer operations.
• Understand the process control strategy for the biotech products.
• Perform data analysis and process monitoring, and be able to assess whether process is in control and capable of meeting its stated purpose and is in a constant state of validation
• Understand and ensure compliance with regulatory expectations
• Have a working knowledge of the manufacturing equipment set and control system
• Understand historic and potential failure modes for the process and equipment
• Document and communicate work and learnings
• Leverage internal and external expertise to improve existing production processes
• Work in a cross-functional team with members of QA, QCL, TSMS Lab, Ops, H&S, Warehouse and bring the deep technical expertise to the team.
• Establish partnership with operations to understand interface between the science/engineering with the operations on the floor.
• Provide technical support during regulatory audits.
• Provide technical expertise during RCA for process deviations/changes.
• Identify and implement process improvements.

Requirements:

• Demonstrated technical capability with high productivity
• Proven track record of curiosity with learning agility
• Demonstrated excellent problem-solving skills
• Self-starter with high initiative and data-driven approach to problem-solving
• Demonstrated ability to participate in and facilitate decision-making
• Demonstrated strong interpersonal skills with demonstrated adaptability and flexibility to working in different environments, teams etc.
• Demonstrated strong verbal and written communication skills
• BSc/MSc in Chemistry, Microbiology, Biotechnology, Biochemistry, Cell Culture or related discipline).