Enterprise Implementation Lead
BioSpace, 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 Horizon 2 Program Technical Accountabilities: The Enterprise Implementation Lead is accountable for the end-to-end technical delivery of the Horizon 2 program across development, process implementation, technology transfer, validation, and the creation of development and technical content required to support global regulatory filings. This includes translating development outputs into scalable, compliant manufacturing solutions and ensuring that process knowledge, control strategies, validation evidence, and regulatory-facing technical narratives are robustly established to enable successful submissions and ongoing deployment as well as new expansion across the CSL network.
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.
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 contact us.
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Role Responsibilities Horizon 2 Program Technical Accountabilities: The Enterprise Implementation Lead is accountable for the end-to-end technical delivery of the Horizon 2 program across development, process implementation, technology transfer, validation, and the creation of development and technical content required to support global regulatory filings. This includes translating development outputs into scalable, compliant manufacturing solutions and ensuring that process knowledge, control strategies, validation evidence, and regulatory-facing technical narratives are robustly established to enable successful submissions and ongoing deployment as well as new expansion across the CSL network.
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.
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 contact us.
#J-18808-Ljbffr