Enterprise Implementation Lead
CSL, Kankakee, IL, United States
Position Purpose
The Enterprise Implementation Lead – Horizon 2 is a senior Technical Operations leadership role accountable for the enterprise-wide technical implementation and validation of the Horizon 2 program. The Horizon 2 program included a patented, yield enhancing manufacturing technology that enables significantly higher immunoglobulin production from the same base amount of plasma. Operating within the Horizon 2 program organization, the role serves as the primary enterprise integrator across Tech Ops, Manufacturing, Quality, Engineering & Maintenance (E&M), and enabling capital projects, ensuring technical intent, process maturity, validation outcomes, program learnings, and regulatory‑facing technical content are coherently translated into effective and sustainable execution at scale.
Role Responsibilities
Lead and integrate technical development activities through to process implementation, ensuring continuity of technical intent and readiness for manufacturing scale‑up
Define and execute enterprise process implementation strategies that convert development learnings into site‑ready, executable solutions across new and existing facilities
Own and coordinate Tech Ops accountabilities for technology transfer, including definition of transfer strategies, critical process parameters, and success criteria across sites
Hold accountability for validation strategy and execution associated with the Horizon 2 program, ensuring validation is risk‑based, inspection‑ready, and aligned with regulatory expectations
Own the development and integration of technical and development content required for regulatory submissions, ensuring consistency between development data, validation evidence, and filing narratives
Ensure alignment between development data, qualification outcomes, validation evidence, and regulatory content to support Manufacturing operational readiness and sustainable GMP production
Drive Right‑First‑Time (RFT) delivery through disciplined technical risk management, issue resolution, and data‑driven decision‑making
Cross‑Functional Collaboration, Integration & Governance
Partner with Manufacturing on Operational Readiness by providing Tech Ops inputs including process knowledge, tech transfer requirements, validation status, and process risk transparency
Partner with Engineering & Maintenance (E&M) in project delivery to ensure Tech Ops process requirements, parameters, and acceptance criteria are clearly defined and aligned with design, construction, qualification, and asset handover expectations
Partner closely with Quality and Regulatory Affairs to jointly develop, review, and approve validation strategies, regulatory submission content, and inspection readiness narratives, ensuring alignment between technical execution and regulatory commitments
Maintain the enterprise‑level technical, validation, and regulatory risk register for the Horizon 2 program, with clear ownership and escalation paths
Serve as the primary technical communication conduit between sites, program leadership, Quality, Regulatory, and governance forums
Team Leadership
Lead a lean, senior Tech Ops‑focused implementation and validation team (direct and matrixed)
Drive enterprise learning, reuse, and continuous improvement across Horizon 2 deployments
Enable effective collaboration across global sites and functions
Qualifications & Experience
Required: Bachelor’s degree in a scientific or engineering discipline (e.g., Pharmaceutical Sciences, Chemical or Biomedical Engineering, Biotechnology, Biology/Chemistry, etc)
Strongly preferred: Advanced degree (MS or PhD)
Preferred: MBA (supports the strategic and business acumen capabilities needed for this role)
15+ years of professional experience in biopharma/biotech/life sciences industry with specific experience in drug development, manufacturing, technical transfer, Validation, CMC regulatory processes, as well as full‑scale MS&T support of GMP manufacturing facilities
Demonstrated leadership of enterprise‑scale programs spanning multiple sites and capital projects
Proven ability to lead in complex, matrixed, global organizations
CSL Leadership & Compliance Expectations The incumbent is expected to operate with an enterprise mindset, demonstrate CSL values, uphold quality and patient safety standards, and comply with all CSL policies, procedures, and regulatory requirements.
CSL Behring is an equal opportunity employer and is committed to diversity, equity, and inclusion in the workplace.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please let us know.
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Role Responsibilities
Lead and integrate technical development activities through to process implementation, ensuring continuity of technical intent and readiness for manufacturing scale‑up
Define and execute enterprise process implementation strategies that convert development learnings into site‑ready, executable solutions across new and existing facilities
Own and coordinate Tech Ops accountabilities for technology transfer, including definition of transfer strategies, critical process parameters, and success criteria across sites
Hold accountability for validation strategy and execution associated with the Horizon 2 program, ensuring validation is risk‑based, inspection‑ready, and aligned with regulatory expectations
Own the development and integration of technical and development content required for regulatory submissions, ensuring consistency between development data, validation evidence, and filing narratives
Ensure alignment between development data, qualification outcomes, validation evidence, and regulatory content to support Manufacturing operational readiness and sustainable GMP production
Drive Right‑First‑Time (RFT) delivery through disciplined technical risk management, issue resolution, and data‑driven decision‑making
Cross‑Functional Collaboration, Integration & Governance
Partner with Manufacturing on Operational Readiness by providing Tech Ops inputs including process knowledge, tech transfer requirements, validation status, and process risk transparency
Partner with Engineering & Maintenance (E&M) in project delivery to ensure Tech Ops process requirements, parameters, and acceptance criteria are clearly defined and aligned with design, construction, qualification, and asset handover expectations
Partner closely with Quality and Regulatory Affairs to jointly develop, review, and approve validation strategies, regulatory submission content, and inspection readiness narratives, ensuring alignment between technical execution and regulatory commitments
Maintain the enterprise‑level technical, validation, and regulatory risk register for the Horizon 2 program, with clear ownership and escalation paths
Serve as the primary technical communication conduit between sites, program leadership, Quality, Regulatory, and governance forums
Team Leadership
Lead a lean, senior Tech Ops‑focused implementation and validation team (direct and matrixed)
Drive enterprise learning, reuse, and continuous improvement across Horizon 2 deployments
Enable effective collaboration across global sites and functions
Qualifications & Experience
Required: Bachelor’s degree in a scientific or engineering discipline (e.g., Pharmaceutical Sciences, Chemical or Biomedical Engineering, Biotechnology, Biology/Chemistry, etc)
Strongly preferred: Advanced degree (MS or PhD)
Preferred: MBA (supports the strategic and business acumen capabilities needed for this role)
15+ years of professional experience in biopharma/biotech/life sciences industry with specific experience in drug development, manufacturing, technical transfer, Validation, CMC regulatory processes, as well as full‑scale MS&T support of GMP manufacturing facilities
Demonstrated leadership of enterprise‑scale programs spanning multiple sites and capital projects
Proven ability to lead in complex, matrixed, global organizations
CSL Leadership & Compliance Expectations The incumbent is expected to operate with an enterprise mindset, demonstrate CSL values, uphold quality and patient safety standards, and comply with all CSL policies, procedures, and regulatory requirements.
CSL Behring is an equal opportunity employer and is committed to diversity, equity, and inclusion in the workplace.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please let us know.
#J-18808-Ljbffr