Biopharma Process Development Scientist: Formulation & Validation

Inteldot; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Inteldot is seeking an Administrative Shift professional to support life science manufacturing initiatives in Puerto Rico with a focus on data analysis, protocol development, and regulatory documentation. The role requires bilingual Spanish/English communication and collaboration across cross-functional teams.

The candidate should bring advanced degree experience and a strong background in protein formulation, process monitoring, and deviation investigations to ensure product quality and

Qualifications

• Experience in commercial biopharmaceutical manufacturing, preferably supporting formulation and aseptic filling.
• 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.

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.

Skills

Bilingual Spanish/English

Data analysis

Statistical analysis

Project management

Cross-functional collaboration

Education

Doctorate

Master’s + 2 years of scientific experience

Bachelor’s + 4 years of scientific experience

Tools

JMP

Job description

Inteldot is seeking an Administrative Shift professional to support life science manufacturing initiatives in Puerto Rico with a focus on data analysis, protocol development, and regulatory documentation. The role requires bilingual Spanish/English communication and collaboration across cross-functional teams.

The candidate should bring advanced degree experience and a strong background in protein formulation, process monitoring, and deviation investigations to ensure product quality and