Principal TSMS Engineer
INCOG BioPharma Services
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Fishers, IN
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Not Applicable
Posted March 28, 2026
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Responsibilities
Responsibilities
- Own and direct the most complex, high-value technical transfer projects with enterprise-wide strategic impact and guide organizational technical strategy from development through commercial manufacturing
- Define and implement company-wide process optimization strategies, advanced manufacturing platforms, statistical process control methodologies, and next-generation platform technologies across all product portfolios
- Lead enterprise-level cross-functional initiatives, serve as executive technical advisor, and influence company-wide strategic decisions across multiple business units
- Design and implement technical career development programs while mentoring Senior II, Senior I, and Entry Level engineers and building world-class organizational technical capabilities
- Author and oversee the most complex technical documents including regulatory submission supporting materials for clients, enterprise risk assessments, CMC strategy documents, Process Validation frameworks, and technical publications for industry leadership
- Serve as executive-level technical advisor to the most strategic clients, represent INCOG in industry forums, and lead enterprise business development initiatives
- Direct complex enterprise-wide root cause investigations for critical manufacturing issues and lead strategic CAPA development initiatives with company-wide impact
- Serve as the company’s lead technical expert during regulatory inspections, agency interactions, and strategic regulatory planning
- Drive technology investment decisions, evaluate emerging manufacturing technologies, and lead digital transformation initiatives across INCOG's operations
- Identify and execute strategic business opportunities through technical innovation, process optimization, cost reduction strategies, and manufacturing efficiency initiatives with transformational business impact
- Establish enterprise-wide technical standards, best practices, and ensure all organizational activities comply with cGMP regulations, company SOPs, and evolving client requirements
- Drive organizational transformation through continuous improvement initiatives, contribute to executive-level strategic decision making, and lead facility capacity planning and expansion initiatives
- Develop comprehensive enterprise risk assessment frameworks, establish technical knowledge management systems, and ensure organizational knowledge transfer and competitive advantage
- Champions and models a growth mindset, highest standards for quality, and the ALP values across the organization
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Requirements
- Minimum 10 years of GMP experience required
- Minimum 6 years of Technical Transfer leadership experience with demonstrated success in complex, high-value programs and organizational impact
- Proven track record of driving organizational change, technical innovation, and successful client relationship management at enterprise level
- Experience with regulatory inspections, submissions, agency interactions, and strategic regulatory planning
- Strong business acumen, understanding of CDMO operations, and experience with executive-level strategic planning
- Excellent presentation and communication skills for executive-level, client, and industry leadership interactions
- Experience leading large teams, developing senior technical staff capabilities, and building organizational competencies
- Expert-level proficiency in statistical analysis software, process validation methodologies, risk assessment tools, and emerging manufacturing technologies
Preferred Skills
- Minimum 6 years of Technical Transfer leadership experience with demonstrated success in complex, high-value programs and organizational impact
- Strong business acumen, understanding of CDMO operations, and experience with executive-level strategic planning
Education
- (Not required) – TSMS – Principal Technical Transfer Engineer
- (Not required) – The Technical Services and Manufacturing Sciences (TSMS) Principal Technical Transfer Engineer represents the highest level of technical expertise within INCOG's Technical Transfer organization and will be responsible for leading enterprise-wide technical strategy, driving organizational innovation, and serving as the ultimate technical authority for Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs.
- (Required) – Bachelor's degree in Science or Engineering required
- (Not required) – Master's degree or PhD in Science or Engineering strongly preferred
TSMS – Principal Technical Transfer Engineer
The Technical Services and Manufacturing Sciences (TSMS) Principal Technical Transfer Engineer represents the highest level of technical expertise within INCOG's Technical Transfer organization and will be responsible for leading enterprise-wide technical strategy, driving organizational innovation, and serving as the ultimate technical authority for Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide site-impacting technical leadership to ensure INCOG maintains industry-leading technical capabilities and competitive advantage.
Essential Job Functions:
Own and direct the most complex, high-value technical transfer projects with enterprise-wide strategic impact and guide organizational technical strategy from development through commercial manufacturing
Define and implement company-wide process optimization strategies, advanced manufacturing platforms, statistical process control methodologies, and next-generation platform technologies across all product portfolios
Lead enterprise-level cross-functional initiatives, serve as executive technical advisor, and influence company-wide strategic decisions across multiple business units
Design and implement technical career development programs while mentoring Senior II, Senior I, and Entry Level engineers and building world-class organizational technical capabilities
Author and oversee the most complex technical documents including regulatory submission supporting materials for clients, enterprise risk assessments, CMC strategy documents, Process Validation frameworks, and technical publications for industry leadership
Serve as executive-level technical advisor to the most strategic clients, represent INCOG in industry forums, and lead enterprise business development initiatives
Direct complex enterprise-wide root cause investigations for critical manufacturing issues and lead strategic CAPA development initiatives with company-wide impact
Serve as the company’s lead technical expert during regulatory inspections, agency interactions, and strategic regulatory planning
Drive technology investment decisions, evaluate emerging manufacturing technologies, and lead digital transformation initiatives across INCOG's operations
Identify and execute strategic business opportunities through technical innovation, process optimization, cost reduction strategies, and manufacturing efficiency initiatives with transformational business impact
Establish enterprise-wide technical standards, best practices, and ensure all organizational activities comply with cGMP regulations, company SOPs, and evolving client requirements
Drive organizational transformation through continuous improvement initiatives, contribute to executive-level strategic decision making, and lead facility capacity planning and expansion initiatives
Develop comprehensive enterprise risk assessment frameworks, establish technical knowledge management systems, and ensure organizational knowledge transfer and competitive advantage
Champions and models a growth mindset, highest standards for quality, and the ALP values across the organization
Other responsibilities as required
Special Job Requirements:
Bachelor's degree in Science or Engineering required
Master's degree or PhD in Science or Engineering strongly preferred
Minimum 10 years of GMP experience required
Minimum 6 years of Technical Transfer leadership experience with demonstrated success in complex, high-value programs and organizational impact
Proven track record of driving organizational change, technical innovation, and successful client relationship management at enterprise level
Experience with regulatory inspections, submissions, agency interactions, and strategic regulatory planning
Strong business acumen, understanding of CDMO operations, and experience with executive-level strategic planning
Excellent presentation and communication skills for executive-level, client, and industry leadership interactions
Experience leading large teams, developing senior technical staff capabilities, and building organizational competencies
Expert-level proficiency in statistical analysis software, process validation methodologies, risk assessment tools, and emerging manufacturing technologies
The Technical Services and Manufacturing Sciences (TSMS) Principal Technical Transfer Engineer represents the highest level of technical expertise within INCOG's Technical Transfer organization and will be responsible for leading enterprise-wide technical strategy, driving organizational innovation, and serving as the ultimate technical authority for Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide site-impacting technical leadership to ensure INCOG maintains industry-leading technical capabilities and competitive advantage.
Essential Job Functions:
Own and direct the most complex, high-value technical transfer projects with enterprise-wide strategic impact and guide organizational technical strategy from development through commercial manufacturing
Define and implement company-wide process optimization strategies, advanced manufacturing platforms, statistical process control methodologies, and next-generation platform technologies across all product portfolios
Lead enterprise-level cross-functional initiatives, serve as executive technical advisor, and influence company-wide strategic decisions across multiple business units
Design and implement technical career development programs while mentoring Senior II, Senior I, and Entry Level engineers and building world-class organizational technical capabilities
Author and oversee the most complex technical documents including regulatory submission supporting materials for clients, enterprise risk assessments, CMC strategy documents, Process Validation frameworks, and technical publications for industry leadership
Serve as executive-level technical advisor to the most strategic clients, represent INCOG in industry forums, and lead enterprise business development initiatives
Direct complex enterprise-wide root cause investigations for critical manufacturing issues and lead strategic CAPA development initiatives with company-wide impact
Serve as the company’s lead technical expert during regulatory inspections, agency interactions, and strategic regulatory planning
Drive technology investment decisions, evaluate emerging manufacturing technologies, and lead digital transformation initiatives across INCOG's operations
Identify and execute strategic business opportunities through technical innovation, process optimization, cost reduction strategies, and manufacturing efficiency initiatives with transformational business impact
Establish enterprise-wide technical standards, best practices, and ensure all organizational activities comply with cGMP regulations, company SOPs, and evolving client requirements
Drive organizational transformation through continuous improvement initiatives, contribute to executive-level strategic decision making, and lead facility capacity planning and expansion initiatives
Develop comprehensive enterprise risk assessment frameworks, establish technical knowledge management systems, and ensure organizational knowledge transfer and competitive advantage
Champions and models a growth mindset, highest standards for quality, and the ALP values across the organization
Other responsibilities as required
Special Job Requirements:
Bachelor's degree in Science or Engineering required
Master's degree or PhD in Science or Engineering strongly preferred
Minimum 10 years of GMP experience required
Minimum 6 years of Technical Transfer leadership experience with demonstrated success in complex, high-value programs and organizational impact
Proven track record of driving organizational change, technical innovation, and successful client relationship management at enterprise level
Experience with regulatory inspections, submissions, agency interactions, and strategic regulatory planning
Strong business acumen, understanding of CDMO operations, and experience with executive-level strategic planning
Excellent presentation and communication skills for executive-level, client, and industry leadership interactions
Experience leading large teams, developing senior technical staff capabilities, and building organizational competencies
Expert-level proficiency in statistical analysis software, process validation methodologies, risk assessment tools, and emerging manufacturing technologies