Senior Manager, Technology Transfer & Contract Development Manufacturing Organization

Posted Yesterday
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14 Locations
Remote
151K-206K Annually
Senior level
Biotech
The Role
Lead end-to-end technology transfers to CDMOs/CMOs and partners, managing transfer strategy, documentation, risk assessments, validation batches, partner performance, regulatory compliance, and cross-functional coordination to enable clinical and commercial manufacturing.
Summary Generated by Built In

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.​

Main Responsibilities & Accountabilities​
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 production​
  • Align 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 stakeholders​
  • Contribute to strategic planning for external manufacturing and partnerships​​

 

Qualifications & Experience Requirements​

  • 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.

About CSL Behring

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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.


You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Skills Required

  • Bachelor's, Master's, or PhD in Chemical, Biochemical, Bioprocess Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or related technical field
  • 7+ years 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, Quality by Design (QbD), and statistical tools (Design of Experiments)
  • Contract governance and vendor performance management
  • Experience supporting regulatory filings and inspections
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The Company
HQ: King of Prussia, PA
20,401 Employees

What We Do

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

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