Senior Technical Transfer Engineer

TSMS Engineer – Senior Technical Transfer II

The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer II will be responsible for supporting all facets of 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 strong technical oversight to the production to ensure robust and reliable production processes are established.

Essential Job Functions:

• Lead multiple complex technical transfer projects simultaneously from development through commercial manufacturing with strategic business impact
• Develop and implement advanced process optimization strategies, statistical process control methodologies, and platform technologies across product portfolios
• Serve as senior technical lead on cross-functional project teams and manage technical workstreams involving multiple engineers
• Provide advanced technical guidance and mentorship to Senior I and Entry Level engineers while developing their technical capabilities
• Author complex technical documents including comprehensive risk assessments, CMC supporting documentation, Process Validation documentation, and strategic technical assessments
• Serve as senior technical advisor to clients, lead high-level technical discussions, and participate in business development activities
• Lead comprehensive root cause investigations for complex manufacturing issues and support the CAPA development team
• Serve as technical expert during regulatory inspections and agency interactions
• Evaluate, select, and implement new manufacturing technologies, equipment platforms, and digital transformation initiatives across the facility
• Identify and drive strategic opportunities for process optimization, cost reduction, and manufacturing efficiency gains with significant business impact
• Establish technical standards and best practices while ensuring all activities comply with cGMP regulations, company SOPs, and client requirements
• Drive continuous improvement initiatives across the organization and contribute to facility capacity planning and strategic decision making
• Develop comprehensive risk assessment frameworks and technical knowledge systems for organizational knowledge transfer
• Maintains and fosters a growth mindset, high standard for quality, and the ALP values
  
  
  

Job Requirements:

• Bachelor's degree in Science or Engineering required
• Master's degree in Science or Engineering strongly preferred
• Minimum 6 years of GMP/ drug product manufacturing experience required
• Minimum 4 years of Technical Transfer experience with demonstrated leadership in complex programs
• Proven track record of successful client relationship management and business development support
• Experience with regulatory inspections, submissions, and agency interactions
• Strong business acumen and understanding of CDMO operations
• Excellent presentation and communication skills for executive-level and client interactions
• Experience managing teams and developing technical staff capabilities
• Advanced proficiency in statistical analysis software, process validation methodologies, and risk assessment tools
  
  
  

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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