Process Development Scientist

CIS International LLC

  • Juncos, PR
  • Autónomo
  • Tiempo completo
  • Hace 8 horas
SUMMARY:
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.FUNCTIONS:
  • Conceives and designs, executes or evaluates, and interprets experimental strategies.
  • Provides input to new processes to generate robust and reliable data.
  • Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
  • Designs, monitors or conducts experimental strategies with general guidance from supervisor.
  • Provides data analysis and interpretation, and assesses impact of the data on the project.
  • Keeps current in field of scientific expertise and areas relevant to their function.
  • Monitors field of expertise, including literature and technology development, and communicates relevant observations.
  • May introduce advanced scientific methods.
  • Develops and implements new and novel protocols to address specific issues.
  • May represent the department on project teams under 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.
  • Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
  • Participates in external scientific community.
  • May assume lead role in department-wide support efforts such as safety, recruiting and committees.
  • May develop supervisory and mentoring skills.
  • Develops and follows timelines for completing project team work.
EDUCATION:
  • Doctorate or Master's + 2 years of Scientific experience.
  • Bachelors + 4 years of Scientific experience.
  • Experience in Regulated Industry.
PREFERRED QUALIFICATIONS:
  • Proficient in creating and executing validation and qualification documentation
  • Provide support to vision inspection qualification and characterizations
  • Requires excellent communication skills with suppliers and other sites
  • A Plus: Knowledge in automated vision inspection systems
  • A Plus: Knowledgeable in CSV. Support CQV documentation and execution
  • Other Considerations: Willing to work during regular business hours, night shift, and/or weekends, as needed to meet the projects’ schedule.
Skills:
  • Advanced scientific analysis and troubleshooting skills.
  • Advanced laboratory work skills.
  • Ability to motivate and/or supervise the activities of others.
  • Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
  • Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolutions
  • Analytical problem solving.
  • Project management.
  • Ability to be flexible and manage change.
  • Computer literacy (Windows environment: Word, Excel, Power Point).
  • Skills requiring the application of scientific theory.
  • Creative skills in the design and performance of scientific experiments and interpretation of results.
  • Strong knowledge of cGMP
  • Fully bilingual (English/Spanish).
WORK METHODOLOGY:
  • Full on site job in Juncos, PR
  • Full time job
  • Expected project duration: 8 months for the first contract, with a high possibility of extension based on performance and budget.
  • Administrative shift from 8:00 a.m. to 5:00 p.m. Due to the nature of the project there will be weeks were we will be working on 12 hour shifts. The resources needs to be aware and in agreement with this.
  • Expected hiring date: April 2026

CIS International LLC

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