Process Development Scientist

QRC; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

QRC Group, LLC is seeking a Process Development Scientist to provide technical support for commercial biopharmaceutical manufacturing, with a focus on formulation and aseptic filling. This role covers process monitoring, troubleshooting, investigations, and driving continuous improvements while ensuring quality and regulatory compliance.

The role requires collaboration with cross-functional teams, knowledge of protein science, and the ability to prepare regulatory documentation.

Qualifications

• PhD in a scientific field or MS with 2+ years of relevant experience; or BA/BS with 4+ years in a scientific field.
• Experience in a commercial biotech manufacturing environment, esp. formulation and aseptic filling.
• Understanding of protein science, formulation processes, and aseptic filling operations.
• Experience with process monitoring, data analysis, trending, and JMP or similar software.
• Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
• Experience providing manufacturing floor support in GMP environment.
• Strong technical writing for regulatory documentation.
• Excellent communication, presentation, problem-solving, and project management skills.
• Ability to collaborate with cross-functional teams.
• Bilingual English and Spanish (written and verbal).

Responsibilities

• Provide technical support for formulation and aseptic filling operations.
• Monitor processes and troubleshoot manufacturing issues.
• Support deviations, investigations, root cause analyses, and product impact assessments.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Prepare documentation for regulatory inspections and audits.

Skills

Technical writing

Communication

Project management

Cross-functional collaboration

Bilingual English/Spanish

Education

Doctorate

Master's degree with 2+ years

Bachelor's degree with 4+ years

Tools

JMP

Job description

Company Description

is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

We are seeking a Process Development Scientist to provide technical support for commercial bio pharmaceutical manufacturing operations, with a primary focus on formulation and aseptic filling processes. This role is responsible for process monitoring, troubleshooting manufacturing issues, supporting investigations, and driving continuous process improvements while ensuring compliance with quality and regulatory requirements. The scientist will collaborate with cross-functional teams to support safe, efficient, and compliant manufacturing operations.

QRC Group, LLC

Qualifications

Requirements

• Must meet one of the following education and experience requirements: Doctorate (Ph.D.) in a scientific discipline; or Master's degree in a scientific discipline with 2+ years of relevant scientific experience; or Bachelor's degree in a scientific discipline with 4+ years of relevant scientific experience.
• Experience in a commercial bio pharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
• Understanding of protein science, formulation processes, and aseptic filling operations
• Experience with process monitoring, data analysis, trending, and statistical software (e.g., JMP)
• Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
• Experience providing direct manufacturing floor support in a fast-paced, GMP-regulated production environment.
• Strong technical writing skills with experience preparing documentation for regulatory inspections and audits.
• Excellent communication, presentation, problem-solving, and project management skills.
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Bilingual proficiency in English and Spanish (written and verbal).
• 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.

All your information will be kept confidential according to EEO guidelines.