Process Development Scientist

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Kelly® Science & Clinical is seeking a Pharmaceutical Principal Investigator for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.

Responsibilities

Strategic Process Development & Scale-Up

• Spearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug products
• Design and lead process characterization and optimization studies, defining critical process parameters and proven acceptable ranges
• Champion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale execution

Technology Transfer Leadership

• Serve as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partners
• Develop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless execution
• Lead high‑performing, cross‑functional teams through knowledge transfer, process mapping, and documentation best practices

Pilot Plant & cGMP Operations Management

• Oversee cGMP‑compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvement
• Drive continuous improvement projects—maximizing efficiency, quality, and yield
• Provide expert troubleshooting and manage deviations, ensuring on‑time project delivery

Capital Projects & Facility Optimization

• Lead equipment qualification and validation for cutting‑edge process installations
• Direct facility expansion and modification projects to support innovation and new technology implementation
• Optimize facility workflows to enhance operational excellence and scalability

Quality Assurance & Regulatory Compliance

• Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations
• Develop and execute robust process validation strategies in accordance with global regulatory standards
• Lead investigations, implement corrective/preventive actions, and maintain perpetual audit readiness

Project Management & Client Engagement

• Manage multiple, high‑profile client technology transfer programs—delivering on time and within budget
• Serve as the primary technical liaison for clients, providing strategic insight and technical guidance
• Develop detailed project plans, risk assessments, and contingency strategies to de‑risk tech transfer activities
• Mentor cross‑functional teams, fostering a culture of excellence and innovation

Qualifications

Education:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferred

Experience:

• 8+ years’ experience (Bachelor’s), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale‑up within a CDMO or CRO environment
• Demonstrated success managing complex, cross‑functional projects in a regulated setting

Technical Mastery

• Deep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualification
• Comprehensive understanding of cGMP, quality systems, and regulatory compliance
• Proven skills in process automation, risk management, and project execution
• Recognized…