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Process Development Scientist- 35091

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:
  • Doctorate or-Master + 2 years of Scientific experience.
  • Bachelors + 4 years of Scientific experience.
  • Academic background in Life Sciences or Engineering (Biochemistry, Chemical Engineering)

PREFERRED QUALIFICATIONS:
  • Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
  • Understanding of protein science, formulation and filling processes.
  • Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP)
  • Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
  • Ability to provide manufacturing floor support in a fast-paced, 24/7 operation.
  • Bilingual proficiency in Spanish and English (written and verbal).
  • Strong technical writing skills with experience preparing documentation for regulatory audits.
  • Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.
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:

  • Full on site job in Juncos, PR
  • Full time job
  • Expected project duration: 9 months for the first contract, with a high possibility of extension based on performance and budget.
  • Administrative shift. Weekends and overtime may also be required.
  • Expected hiring date:  March 2026

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