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Open nowPosted 5 days ago

Process Development Sr Scientist ID 35534

inteldot18 open roles

Where
Juncos, Puerto Rico
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Your applicationOpen nowProcess Development Sr Scientist ID 35534inteldot · Juncos, Puerto Rico

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This job: posted 5 days ago

The posting

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift - 8:00AM – 5:00PM

Description:

To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities. Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.

Responsibilities:

  • Designs, monitors, or conducts strategies with general guidance from the supervisor.
  • Provides data analysis and interpretation and assesses the impact of the data on the project. Keeps current in technical expertise and areas relevant to their function.
  • Monitors field of expertise, including literature and technology development, and communicates relevant observations.
  • Develop and implement new and novel protocols to address specific issues.
  • May represent the department on project teams under the supervision of a senior scientific staff member.
  • May initiate productive collaborations within and outside of the department or company.
  • Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
  • Able to develop solutions to routine technical problems of limited scope.
  • Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.

Job Requirements:

  • Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
  • Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
  • Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
  • Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
  • Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
  • Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
  • Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
  • Strong technical writing, communication, presentation, and project management skills.
  • Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
  • Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable
  • Experience with technical data analysis and scientific documentation

Education:

  • Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience.
  • A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.
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