Senior Manager Commercial Readiness, Business Systems

The Role:

ElevateBio is looking for an outstanding candidate to represent IT on a cross-functional Commercial Readiness team. This role is responsible for supporting commercial readiness gap assessment and mitigation activities to prepare our facility and company for Phase 3/commercial manufacturing for US and EU markets. You’ll work collaboratively with internal subject matter experts and consultants to develop and implement procedural, technical, and business process updates according to a defined project plan. Candidates should have extensive experience with manufacturing and the technologies that support it in a cGMP facility, specifically in later phase assets.

This role will report into the Director of IT, Computer Systems Validation with dotted line reporting to the Commercial Readiness program lead and team. The successful candidate will initially support Commercial Readiness program activities and is expected to transition to a full-time role as a Business Systems Analyst (BSA), or equivalent, after the implementation of the project is complete (approximately 12 months). The BSA will be primarily responsible for creating and maintaining business process workflows to ensure alignment with business strategy with a focus on efficiencies, quality, and compliance.  The BSA will collaborate cross-functionally with many stakeholders to gather and document business objectives, requirements, and measures of success.  To be successful in this role the candidate should have a deep understanding of current technology trends and experience in applying them to Quality and Manufacturing operations.     

Here’s What You’ll Do (Commercial Readiness):

• Lead, facilitate, collaborate, and track workstream deliverables for Commercial Readiness project.
• Author and review updates to Standard Operating Procedures, Policies, Risk Assessments, and other documentation in accordance with project schedule and plan. 
• Direct ownership of documentation and support/review of other functional documentation that is part of the project.
• Develop implementation and remediation plans as part of the deployment of new policies, procedures, and programs. Support remediation of any gaps.
• Partner with CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets to ensure appropriate quality processes and procedures are implemented for commercial cell-therapy GMP manufacturing, at-scale and in-compliance.

Here’s What You’ll Do (Business Systems Analyst):

• Conduct thorough analysis of existing manufacturing and quality processes to identify inefficiencies, bottlenecks, and areas for improvement. Support system integration strategy and implementation, as needed. This may include process mapping of current cGMP manufacturing systems and processes, identification of improvement opportunities, and gap closure.
• Collaborate with stakeholders to define and document business requirements, objectives, and key performance indicators (KPIs).
• Design and implement process improvements, leveraging innovative solutions to enhance quality, compliance, efficiency.
• Maintain all relevant business process maps in alignment with business directions and strategies. 
• Use digital tools to extract insights for future improvements of systems and processes.
• Drive alignment and consensus on process improvements and system implementations.
• Develop communication plans and lead change management initiatives to drive the adoption of new processes, systems, and technologies.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Science, or related equivalent experience.
• At least 8 years of experience as a business systems analysis in a GMP environment supporting complex products and applications. 
• Direct experience working in a commercial manufacturing facility strongly preferred.
• Experience in autologous/allogeneic cell therapies or gene therapies is a plus.
• Experience with regulatory guidelines (ex. FDA CFR, EU EudraLex/Annex), specifically 21CFR part11 and EU GMP Annex 11. 
• Experience administering GxP Manufacturing or Quality applications a plus. (e.g. Veeva, Apprentice, SAP etc.)
• Proficiency in process analysis and visualization tools (e.g., Signavio, Lucid Charts, Miro, Tableau).
• Excellent communication, presentation, and interpersonal skills.
• Proven ability to work effectively in cross-functional teams and drive consensus among stakeholders.
• Certification in Lean Six Sigma or Business Process Management (BPM) is a plus.