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).