Senior Manager, Technology Transfer & Contract Development Manufacturing Organization

The Senior Manager of Technology Transfer & Contract Development Manufacturing Organizations (TT & CDMO) leads the planning and execution of technology transfer activities to external partners, including CDMOs, CMOs, and strategic collaborators. This role ensures successful transfer of processes, analytical methods, and manufacturing knowledge while maintaining quality, compliance, and timelines. The position also manages external relationships to support development, scale-up, and commercial manufacturing across the product lifecycle., Technology Transfer Leadership:

• Lead end-to-end technology transfer to external manufacturing and development partners
• Develop and execute tech transfer strategies, plans, and timelines
• Ensure successful transfer of process, analytical, and quality knowledge
• Oversee preparation of transfer documentation, risk assessments, and technical packages
• Monitor execution of engineering, demonstration, and validation batches

External Partner Management:

• Manage relationships with CDMOs, CMOs, and strategic partners
• Serve as primary technical and operational contact for external collaborations
• Evaluate partner technical capabilities, capacity, and compliance status
• Drive alignment on deliverables, timelines, and performance expectations
• Support contract scope definition and governance processes

Cross-Functional Coordination:

• Collaborate with Process Development, MSAT, Manufacturing, Quality, Regulatory, and Supply Chain
• Ensure readiness for clinical and commercial manufacturing at external sites
• Coordinate troubleshooting and issue resolution during transfer and productionAlign internal and external teams on project milestones and risks

Quality & Compliance:

• Ensure compliance with GMP, regulatory, and quality standards during technology transfer
• Support deviations, investigations, CAPA, and change control related to external manufacturing
• Ensure proper documentation and data integrity across partner activities
• Support audits, inspections, and regulatory submissions

Program & Project Management:

• Manage multiple technology transfer projects simultaneously
• Track milestones, risks, budgets, and performance metrics
• Drive continuous improvement in tech transfer processes and best practices
• Support lifecycle management and post-transfer optimization

Leadership & Influence:

• Mentor scientists and engineers involved in tech transfer activities
• Influence cross-functional and external stakeholdersContribute to strategic planning for external manufacturing and partnerships

Do you have experience in Vendor relationship management?, Do you have a Master’s degree?, * Bachelor’s, Master’s, or PhD in: Chemical / Biochemical / Bioprocess Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or related technical field

• 7+ years of experience in technology transfer, process development, MSAT, or manufacturing
• Strong experience working with CDMOs/CMOs and external partners
• Solid understanding of GMP, regulatory expectations, and quality systems
• Proven project and stakeholder management experience
• Strong technical understanding of process scale-up and manufacturing
• Global technology transfer and external manufacturing networks
• Process validation and commercial manufacturing support
• Risk management, QbD, and statistical tools (DoE)
• Contract governance and vendor performance management
• Experience supporting regulatory filings and inspections

The expected base salary range for this position in Illinois at hiring is $151,000 - $179,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

The expected base salary range for this position in Massachusetts at hiring is $174,000 - $206,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

(part of CSL) 2.92.9 out of 5 stars Waltham, MA $151,000 - $206,000 a year - Full-time

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.