Process Development Scientist II

4 weeks ago


Singapore VALERE SG PTE. LTD. Full time
Roles & Responsibilities

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)



Tell employers what skills you have

qPCR
Troubleshooting
Upstream
Process Validation
EDA
Purification
Titration
Laboratory Techniques
Unit Operations
Experimental Design
Customer Development
PCR
Instrumentation
Laboratory
Manufacturing
Cell Therapy
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