Principal Investigator, Oral Solids

Kelly® Science & Clinical is seeking a Principal Investigator, MSAT 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.

** Workplace:
** Onsite in Colorado Springs, CO

** Salary:**  $,000

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.

** Key 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 & Experience*
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* Education:

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

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* Experience:

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* + 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

** Leadership & Collaboration*
* + Recognized leadership in guiding technical teams and cross-functional project groups

+ Outstanding client relationship management and communication abilities

+ Strategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teams

** Why Join Us?*
* + Work alongside industry leaders and innovators

+ Participate in high-impact projects accelerating life-saving therapies to market

+ Competitive salary, comprehensive benefits, and opportunities for continued professional growth

If you are ready to lead advancements in pharmaceutical process development and play a pivotal role in our growth, we want to hear from you!

** What happens next:*
* Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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