About The Position

The Process Development Scientist conceives, designs, implements, and executes scientific experiments that contribute to project goals under the general guidance of a supervisor. The role includes developing and implementing protocols, analyzing and interpreting data, monitoring technical developments, and advising others on experimental design and data interpretation. The position may represent the department on project teams under the supervision of senior scientific staff and may initiate collaborations within and outside the department or company. The scientist develops solutions to routine technical problems of limited scope and applies a comprehensive understanding of validation protocol execution requirements and validation processes for new equipment installations. The work includes preparing syringes and vials with cosmetic, particle, or solution defects for developmental studies, equipment characterization, training, and commercial equipment setup.

Requirements

  • Doctorate, or a master's degree and 2 years of scientific experience, or a bachelor's degree and 4 years of scientific experience.
  • Experience preparing syringes and vials with cosmetic, particle, or solution defects for developmental studies, equipment characterization, training activities, and commercial equipment setup.
  • Experience using laboratory equipment and instruments, including calipers, microscopes, and analytical balances.
  • Strong manual dexterity, creativity, and practical problem-solving skills, including the ability to develop and create defects in glass containers.
  • Exceptional fine motor skills and the ability to handle, cut, shape, and craft miniature items precisely, including preparing particles and creating defects for laboratory studies.
  • Knowledge of aseptic techniques, 5S, Lean Manufacturing, and visual manual inspection techniques.
  • Proficiency with AI tools to support research, information organization, and workflow improvement, using sound judgment and following applicable company requirements.
  • Strong organizational and multitasking skills, including experience coordinating projects and working with other departments.
  • Ability to work in a fast-paced environment and prioritize competing tasks.
  • Excellent interpersonal and communication skills, with the ability to work effectively with internal and external customers.
  • Comprehensive understanding of validation protocol execution requirements.
  • In-depth knowledge of validation processes as applied to new equipment installations.

Responsibilities

  • Design, monitor, or conduct strategies under general guidance from the supervisor.
  • Provide data analysis and interpretation and assess the impact of data on projects.
  • Keep current in technical expertise and areas relevant to the function.
  • Monitor relevant literature and technology developments and communicate observations.
  • Develop and implement new protocols to address specific issues.
  • Represent the department on project teams under the supervision of senior scientific staff, as needed.
  • Initiate productive collaborations within and outside the department or company, as needed.
  • Advise or assist others with experimental design, data interpretation or diagnosis, and implementation of innovative remedies.
  • Develop solutions to routine technical problems of limited scope.
  • Prepare syringes and vials with cosmetic, particle, or solution defects for developmental studies, equipment characterization, training activities, and commercial equipment setup.
  • Develop, introduce, or improve methods for creating defects for laboratory use and evaluate defects and other conditions in primary containers.
  • Manage projects of limited scope under general direction.
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