As a Process Development Specialist in the downstream sector of the pharmaceutical industry, you will contribute to the development and optimization of purification processes for pharmaceutical products. Working under the guidance of senior team members, you will be involved in experimental design, data analysis, and technology transfer activities. This role requires a strong foundation in scientific principles, a keen interest in downstream processes, and the ability to work collaboratively within a dynamic team.
Responsibilities:
- Plan and conduct experiments to develop and optimize downstream processes.
- Conduct various analytical testing to support modeling studies, process continuous improvement, process optimization, troubleshooting, investigation, and new product introduction.
- Perform data analysis based on the analytical result and communicate effectively to the cross-functional teams.
- Collaborate with cross-functional teams to support the successful transfer of downstream processes from development to manufacturing.
- Compile and analyze process data using tools such as excel, minitab, JMP
- Provide internal and external support for method transfer activities and analytical support for manufacturing small-scale modeling studies.
- Provide support as required in any process characterization studies to understand the critical process parameters and their impact on product quality.
- Maintain accurate and detailed records of experiments, processes, and results in accordance with GDP, GMP and GLP standards.
- Adhere to cGMP and GLP principles and assist in ensuring compliance with regulatory requirements.
- Review documents as part of the activities’ requirements
About You:
- Master's Degree or Bachelor's Degree in a scientific or engineering discipline (Biochemistry, Biology, or related field) with 2 years of relevant experience
- Take ownership to drive the progress of the deliverables
- Understanding of GDP, cGMP and GLP.
- Preferably with experience in Biopharma downstream manufacturing and analytical testing
