Senior Manager, Commercial Readiness Lead Technical Operations

The Role:

ElevateBio is looking for an outstanding candidate to represent Technical Operations 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, system, and business process updates according to a defined project plan. Candidates should have extensive experience with manufacturing in a GMP facility, specifically in later phase assets.

This role will initially fully support Commercial Readiness program activities and will transition to a full-time role within MSAT/Technical Operations after the implementation of the project is complete (approximately 12 months). This role will report into the MSAT/Technical Operations function with dotted line reporting to the Commercial Readiness program lead and team.

Here’s What You’ll Do:

• Draft, write, and review updates to Standard Operating Procedures, Policies, Risk Assessments, and other documentation in accordance with project schedule and plan.  Direct ownership of Technical Operations owned documentation and support/review of other functional documentation that is part of the project.
• Develop implementation plans and remediation plans as part of the implementation of new policies and programs. Support any gaps in compliance and remediation activities.
• Partner with Quality, CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Science, or related field.
• At least 8 years of experience in a Manufacturing, Technical Operations, Quality or GMP environment supporting complex products. Experience in autologous/allogeneic cell therapies or gene therapies is a plus.
• Direct experience working in a commercial manufacturing facility strongly preferred
• Experience and/or familiarity with regulatory guidelines (ex. FDA CFR, EU EudraLex/Annex) is a plus
• Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.