Process Development Sr Scientist

Inteldot; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Inteldot, with over 15 years in life sciences, seeks a senior role in Puerto Rico to join a leading client. The position focuses on the conception, design, and execution of scientific experiments under supervisor guidance.

The role requires supporting sterile drug product manufacturing, aseptic filling operations, validation, and cross-functional collaboration in a fast-paced setting; English/Spanish fluency is essential.

Qualifications

• Experience supporting sterile drug product manufacturing in pharma/biotech.

Responsibilities

• Designs, monitors, or conducts strategies with supervision guidance.
• Provides data analysis and interpretation and assesses impact of data on the project.
• Monitors field of expertise; reads literature and tracks tech developments.
• Develop and implement new protocols to address issues.
• May represent the department on project teams under supervision.
• May initiate productive collaborations within/outside the department.
• Advises or assists others in experimental design and/or data interpretation.
• Develop solutions to routine technical problems of limited scope.
• Understand validation protocol execution requirements and knowledge of validation for new equipment.

Skills

Technical writing

Communication

Presentation

Project management

Education

PhD/PharmD/MD in relevant field

Master's degree + 3+ years

Bachelor's degree + 5+ years

Tools

JMP

Minitab

LIMS

HLEE

Excel

PowerPoint

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.

Administrative Shift - Monday-Friday, 8:00 AM - 5:00 PM (or standard business hours). Availability to work on weekends as needed. All shifts.

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:

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.
• Experience with technical data analysis and scientific documentation.
• Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required.
• Experience with Sample Management System such as LIMS and HLEE.
• Fully bilingual (English/Spanish).

Education:

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable
• Master's degree with 3+ years of relevant scientific experience; or bachelor's degree with 5+ years of relevant scientific experience.
• A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.