Process Development Scientist- 35588

Cis-International-LLC; Juncos (PR); On-site; USD 60,000 - 100,000; Full time

Job summary

Cis-International-LLC in Juncos, PR is seeking a scientist to conceive, design, implement and evaluate experimental strategies under supervisor guidance. The role focuses on robust data generation, regulatory-compliant studies, and cross-functional collaboration in a fast-paced biopharma environment.

This is a full-time, on-site position with an expected four-month project duration and potential extension based on performance and budget.

Qualifications

• PhD or MS with 2+ years scientific experience, or BA with 4+ years.
• Experience in biopharmaceutical manufacturing, formulation and aseptic filling.
• Knowledge of protein science, formulation, and filling processes.
• Experience with deviations, investigations, root cause analyses.
• Bilingual English/Spanish, written and verbal.
• Strong regulatory documentation writing skills.

Responsibilities

• Conceives and designs, executes or evaluates experimental strategies.
• Provides data analysis and interpretation for projects.
• Ensures studies comply with protocols and regulations.
• Develops and implements new experimental protocols.
• Authors scientific reports and regulatory documents.
• Represents department on project teams under supervision.
• Collaborates across departments to address issues.

Skills

Scientific analysis

Troubleshooting

Verbal communication

Written communication

Project management

Analytical thinking

Experiment design

Cross-functional collaboration

Education

Doctorate or Master’s + 2 years of scientific experience

Bachelor’s + 4 years of scientific experience

Tools

JMP

Excel

Job description

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 orMaster’s + 2 years of Scientific experience.
• Bachelors + 4 years of Scientific experience.

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: 4months for the first contractwith a high possibility of extension based on performance and budget.
• Work schedule: 8:00 am to 5:00 pm (admin shift). However, staff will support a 24/7 formulation and filling operations, and irregular shifts, including extended hours (12 hrs.), nights, weekends, or holidays may be required based on business needs.
• Expected hiring date: August 2026