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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Process Development Scientist, APIs

Colorado Springs, CO

Full-time

Onsite

Senior Level

$125K/yr - $140K/yr

5+ years exp

Kelly Science & Clinical is seeking a Process Development Scientist for a direct hire opportunity with a leading small molecule CDMO. The role involves driving innovation in pharmaceutical manufacturing by overseeing process development, technology transfer, and ensuring compliance with regulatory standards.

Staffing & Recruiting

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

Pharmaceutical process developmentTechnology transferProcess validationCGMP complianceProcess automationRisk managementProject managementClient relationship managementLeadershipCollaborationCommunication

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