Principal Process Scientist

JC Automation Corp • Manatí, PR

11d

About The Position

We are seeking a Principal Process Scientist to serve as the Subject Matter Expert (SME) for sterile manufacturing processes, with specialized focus on liquid and lyophilized parenteral products. This senior-level role combines deep scientific expertise with hands-on operational support, driving process optimization, compliance, and technology transfer in a cGMP pharmaceutical environment. The ideal candidate brings extensive experience in manufacturing operations, complex investigations, process validation, and cross-functional leadership, ensuring strategic alignment with site priorities and regulatory requirements.

Requirements

• Bachelor's, Master's, or Ph.D. in Life Sciences, Chemical Engineering, Pharmacy, Bioengineering, or a closely related scientific discipline.
• Extensive background in sterile manufacturing processes with specialized focus on liquid and lyophilized parenteral products.
• Proven experience supporting daily manufacturing operations and providing advanced technical troubleshooting.
• Demonstrated capability in managing complex investigations, root cause analysis, and CAPA implementation.
• Hands-on experience executing process validation activities and leading technology transfer efforts.
• Deep understanding of cGMP regulations, FDA guidelines, and compliance requirements in a highly regulated pharmaceutical environment.
• Exceptional cross-functional collaboration skills with manufacturing, engineering, quality, and validation teams.

Nice To Haves

• Ph.D. or advanced degree with focus on sterile pharmaceutical manufacturing or bioprocessing.
• Experience supporting FDA or EMA regulatory inspections as a process SME.
• Familiarity with lyophilization process development and scale-up.
• Experience with statistical tools for process monitoring and data analysis (e.g., JMP, Minitab).

Responsibilities

• Serve as the primary technical authority for sterile manufacturing processes, including liquid and lyophilized parenteral products, providing guidance to manufacturing, engineering, quality, and validation teams.
• Support daily manufacturing operations with advanced technical expertise, ensuring processes operate within validated parameters and in compliance with cGMP and site procedures.
• Lead technical troubleshooting efforts for manufacturing deviations and process-related issues. Drive continuous process optimization to improve yield, efficiency, and product quality.
• Lead and manage complex investigations, including root cause analysis for deviations. Develop and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
• Plan and execute process validation activities, ensuring all protocols, reports, and supporting documentation meet regulatory and internal standards.
• Lead technology transfer efforts for new or existing products, coordinating with cross-functional teams to ensure successful scale-up and site integration.
• Ensure strict adherence to cGMP regulations, FDA guidelines, and internal site procedures. Support regulatory inspections and audits as the technical SME for sterile manufacturing processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree