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Process Development Scientist- 34490

Juncos, Puerto Rico
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:
  • Master + 2 years of Scientific experience.
  • Bachelors + 4 years of Scientific experience.
  • Chemical Engineering, Mechanical Engineering, Other Engineering, Chemistry or Biology
Preferred Qualifications:
  • Formulation and Filling experience preferred. Not required if PhD.
  • Academic background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).
  • Experience with protein science, formulation and filling processes.
  • Process Monitoring and statistical tools.
  • Experience in technology transfer and process validation life cycle.
  • Experience supporting deviations, product impact assessments, and floor support.
  • Bilingual in Spanish and English.
  • Strong communication, problem-solving, and project management skills.
  • Proficiency in Microsoft Office and JMP, and/or Minitab
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 resolution. 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:

  • 100% On-site 
  • 12 months (1st Contract)
  • Administrative Shift (weekends and overtime may also be required).
  • Professional Service Contract 

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