Kelly · 1 day ago
Process Development Scientist
Colorado Springs, CO
Full-time
Onsite
Senior Level
$125K/yr - $140K/yr
5+ years expKelly Science & Clinical is seeking a Process Development Scientist for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. The role involves driving innovation in pharmaceutical manufacturing, serving as a technical authority in process development, scale-up, and technology transfer.
OutsourcingProfessional Services
Hiring Manager
Alexandre Neves, Ph.D.
Responsibilities
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
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
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
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
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
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
Qualification
Required
Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field
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
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 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
Preferred
advanced degree (MS/PhD)
Benefits
Competitive salary
Comprehensive benefits
Opportunities for continued professional growth
Company
Kelly
We’ve been helping organizations find the people they need longer than any other company in the world.
10001+ employees
H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Chris Layden
Chief Executive Officer
N
Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
Recent News
Kelly Services, Inc.
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