Kelly® Science & Clinical is seeking a Senior Process Engineer, Oral Dosage Forms 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: $125,000-150,000
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
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
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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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
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