Senior Manager, CMC Operations and Program Management

The Role:

ElevateBio is looking for an outstanding candidate to join our CMC Operations and Program Management department in support of our growing client portfolio for genomic medicines. This role is responsible for organizing process performance qualification (PPQ, process validation) and commercial readiness activities in support of advanced therapies. The Manager will lay the organizational foundation for the process validation program while integrating all essential deliverables from the cross-functional team. Candidates should have extensive experience with program management, biologics/CGT manufacturing in a commercial GMP setting, PPQ planning and execution, supporting regulatory filing and inspections, and working within highly matrixed cross-functional team

Here’s What You’ll Do:

• Lead and manage commercial readiness and PPQ activities ensuring the team stays on track with promised deliverables.
• Run daily and weekly coordination meetings to ensure all activities that impact PPQ readiness are managed and resolved effectively
• Develop a fully-integrated timeline for PPQ readiness inclusive of all cross-functional activities and actively manage to keep program on time
• Contribute to the overall framework for PPQ approach
• Anticipate and manage risks to PPQ timeline, implementing mitigation strategies where possible
• Collaborate with cross-functional teams, including external client teams as well as internal Quality, Regulatory Affairs, and Manufacturing, to ensure seamless execution of PPQ activities.
• Ensure the preparation and review of PPQ protocols, reports, and related documentation occur according to plan.
• Manage the timing of the design and execution of supporting BLA enabling studies such as filter validation, shipping validation, aseptic process validation etc
• Establish and support life cycle management program for post approval changes.
• Ensure successful delivery of commercial batches in partnership with MSAT, Manufacturing, Supply Chain, Quality and supporting functions by providing oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition.
• Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.)
• Actively support PAI readiness and regulatory inspections of BaseCamp Waltham site

Requirements:

• B.S. in a scientific or engineering discipline
• At least 5 years of experience in CMC program management. Experience in autologous gene or cell therapy preferred.
• PPQ oversight and program leadership for process validation is required
• Demonstrated ability and strength in leading cross-functional technical teams within a matrixed organization.
• A strong technical leader who can problem solve while balancing business needs with technical risks within a regulated environment.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ICH guidelines).
• Prior experience with regulatory submission and regulatory inspection is strongly preferred
• Excellent project management, organizational, and communication skills including communication with senior leadership and external stakeholders.
• Outstanding planning, organization, and multitasking skills
• Experience working within a contract manufacturing or client service organization strongly preferred.
• On-site presence required – routine interface with commercial readiness team on-site (role may be hybrid)