Responsibilities
- Interact with the client partner on a daily or weekly basis to analyze their existing process for transferability and scalability
- Prepare and follow standard operating procedures, batch records, and other process documentation
- Manage the internal process development technicians and interns in proper laboratory techniques and scientific experimental design as necessary
- Design and troubleshoot experiments for testing various unit operations in process development in accordance with clients need and company’s overall strategic goals
- Analyze internally or externally generated experimental data using standard process development tools and algorithms
- Design and test process control strategies
Requirements
- PhD in bioprocessing, biochemical engineering, pharmaceutical science, chemical engineering or equivalent
- Work authorization in Singapore
- 1-5 years of work experience within bioprocessing or equivalent
- Make detailed observations about experimental deviations from the expectations and carries out analysis / troubleshooting of the experimental data.
- Maintain / calibrate associated equipment and instrumentation. Schedules periodic maintenance for laboratory equipment.
- Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements : documents operations, observations, and results in laboratory notebooks (including electronic).
- Act as a project team member (representing Singapore PD) for customer development programs, acting as spokesperson on associated Singapore PD activities and interacting positively and productively with clients
- Advising management on program status
- Demonstrable proficiency designing and troubleshooting upstream process experiments
- Demonstrable proficiency with wave, stir tank, perfusion bioreactor systems
- Demonstrated proficiency with compendial methods (e.g. pH, Osmolality, Karl Fisher titration, etc.), gels, bioassays and immunoassays
- Demonstrable rudimentary EDA and statistical analysis proficiency (using Prism or R or equivalent)
- Ability to work in BSL2 lab
Desired Qualifications
- Demonstrable strong understanding of cell line development, upstream and downstream, and fill/finish integrating within an integrated manufacturing context
- Experience with ACTG manufacturing including cell therapy, viral gene therapy or nucleic acid therapies
- Innovative and analytical thinker with outstanding interpersonal, communication, and leadership skill
- Demonstrated ability to clearly communicate technical information and roadmaps through written protocols and/or presentations containing clean figures and visualizations
- Strong demonstrable experimental planning/troubleshooting skills
- Experience with Unicorn, Electronic laboratory notebooks, DoE / Statistical software (i.e. JMP, DesignExpert)
- Strong demonstrable EDA fundamentals (including data tidying, analysis, interacting with data lakes or data warehouses, first order analysis of data sets, drawing inferences using R or equivalent)
