Advanced Technical Leader

1 day ago

Singapore beBeeProcess Full time $90,000 - $105,000
Scientific Leadership

We seek a highly skilled Process Development Engineer to provide technical leadership within our Process Development group.

This role involves assuming a Subject Matter Expert role for cell culture and commercial process support, technology transfer, and process characterization.

The successful candidate will lead small teams, manage key projects, and collaborate with cross-functional teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.

Experience in regulated environments, in-depth cell culture process knowledge, and strong communication skills are required.

Familiarity with documentation in a highly regulated environment and ability to provide solutions to a large variety of technical problems is desired.

Key Responsibilities:

  • Assume a Subject Matter Expert role within the Process Development group for cell culture and commercial process support.
  • Experienced in Technology Transfer of new processes and technologies to commercial sites.
  • Must have strong knowledge of cell culture and product recovery.
  • Must have good understanding of process characterization and process scale up to resolve technical issues observed during transfer/manufacturing at large scale.
  • Able to lead small teams and lead projects focused on non-routine activities including facility start up, process qualification through to regulatory filing, process performance monitoring, floor support, and troubleshooting of unit operations.
  • Integrate trends, data and information into plans, deliverables and recommendations.
  • Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
  • Lead productivity projects, process optimization, complex investigation, and product life cycle management.
  • Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.

Qualifications:

  • Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience.
  • Relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries.
  • Experience with regulated environments (i.e. cGMP) required.
  • In-depth cell culture process knowledge, including disposables technologies and harvest technologies.
  • Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production.
  • Comprehensive understanding of commissioning, qualification and verification protocol execution requirements.
  • Comprehensive experience in process characterization and process monitoring programs.
  • Strong communication skills (technical writing and verbal communication/presentation).
  • Problem-solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
  • Familiarity with documentation in a highly regulated environment.
  • Interacts effectively with variety of communication and working styles.
  • Ability to independently determine when additional resources are required to solve problems.
  • Demonstrated skills in the following areas: Basic project management, Commissioning and Qualification, Scheduling, Collaboration, Completion and follow-up, Ability to provide solutions to a large variety of technical problems.

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