Process Development Scientist ID 35588

Inteldot; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot is seeking a scientifically experienced professional to join our client in Puerto Rico. The role involves conceiving and executing experiments, analyzing data, and interpreting results to advance projects in a fast-paced, cGMP environment.

The candidate will monitor literature, develop new protocols, and collaborate across departments to address issues and optimize processes. Experience with regulatory documentation and cross-functional teamwork is essential.

Qualifications

• Experience with data analysis and interpretation for biopharmaceutical projects.
• Strong written and verbal communication; preparation of regulatory documents.
• Ability to design and optimize experiments in a GMP environment.
• Knowledge of validation concepts and quality systems.

Responsibilities

• Conceive, design, implement and execute scientific experiments.
• Provide data analysis and interpretation; track trends and impacts on projects.
• Monitor literature and technology developments relevant to the function.
• Develop and implement new protocols to address issues.
• Collaborate with department or project teams under supervision.
• Support deviations, investigations and root cause analysis as needed.
• Assist with experimental design and data interpretation across teams.

Skills

Data analysis

Cross-functional collaboration

Biopharmaceutical knowledge

Regulatory writing

Education

Doctorate

Master’s + 2 years of experience

Bachelor + 4 years experience

Tools

JMP

Job description

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Non Standard Shift

Description

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.

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.

Job Requirements

• 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.

Education

• Doctorate OR Master’s + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience