Process Scientist

Job Overview

An excellent opportunity awaits for a Process Scientist to become a key contributor within our vaccine manufacturing MSAT laboratory. This role focuses largely on providing technical support for upstream and downstream lab-scale experiment planning and execution.

Key Responsibilities

• Lead and assist small-scale upstream and downstream studies in the MSAT lab.
• Manage cell culture seed trains and facilitate smooth setup and operation of bioreactors.
• Handle tangential flow filtration (TFF), clarification, filtration, and drug substance dilution processes efficiently.
• Possess strong expertise in upstream and/or downstream process development and corresponding scale-down models.
• Compile and deliver high-quality reports and data presentations within the team.
• Exhibit flexibility to support weekend work as required.
• Support manufacturing activities during engineering runs, validation, and clinical batch executions.
• Assist satellite vaccine production runs to ensure consistent and effective manufacturing.
• Bring thorough knowledge of vaccine drug substance processes along with a drive for troubleshooting and process enhancement in a GLP-compliant environment.
• Maintain meticulous records and documentation for experiments and investigations.
• Contribute to the drafting and revision of SOPs, protocols, master batch records (MBRs), technical memos, and other technical documentation.
• Collaborate closely with MSAT and drug substance technical teams to provide comprehensive manufacturing guidance.
• Support project-related equipment qualifications including commissioning, qualification, and installation/operational qualification (IOQ) phases.
• Identify and implement continuous improvement projects to enhance compliance and manufacturing capabilities within the drug substance MSAT lab.
• Leverage experience in cell culture process development, bioreactor operations, downstream processing, and bioprocess/biopharmaceutical production or validation.
• Apply knowledge of biopharmaceutical cGMP quality systems, with biological production process validation experience considered an advantage.
• Demonstrate excellent oral presentation abilities for both internal and external meetings.
• Maintain strong organizational attention to detail for effective project tracking and management.
• Conduct troubleshooting and investigations of critical deviations, perform risk analyses on production processes, coordinate technical transfers, and oversee process validations.

Qualifications and Experience

• Master's or Bachelor's degree in Biology, Biotechnology, Microbiology, Chemistry, Pharmaceutical Engineering, or a related Science or Engineering discipline, or equivalent experience.
• At least 2 to 3 years of professional experience within biological or vaccine clinical or commercial manufacturing environments.