Sr. Manager, CMC Operations Program Management

The Role:

The Senior Manager of CMC Operations & Program Management will lead the cross-functional activities among CMC groups and other departments at Life Edit Therapeutics, Inc. (LETI), ElevateBio BaseCamp and contract development and manufacturing organizations (CDMOs) to drive LETI’s gene editing pipeline, including process development, analytical development, technical operations, facilities and engineering and supply chain within the scope of various programs. This individual will be a part of the ElevateBio BaseCamp Commercial Operations and CMC Program Management department, with a dotted line to LETI Technical Operations, and will aid in supporting both internal and external partners for LETI-driven programs. This position will contribute to ensuring alignment with corporate goals and timelines through project and program management.

Here’s What You’ll Do:

• Build and maintain strong internal relationships with CMC SMEs at LETI and ElevateBio BaseCamp (PD, Tech Ops, Manufacturing, AD/QC, QA, Regulatory, Supply Chain, Commercial) and external relationships with scientific and program management staff at partner organizations and CDMOs to ensure program goals are met and accountabilities are clear
• Develop, maintain, and track CMC project plans (e.g., detailed Gantt charts, budget, resources, etc.) with internal and external CMC SMEs and other project managers to encompass key program milestones and deliverables in alignment with overall program objectives with experience/familiarity in the following:
• Own the CDMO project management relationship and support tech transfer and CDMO management with LETI and ElevateBio Base Camp SMEs
• Proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams and functional leadership to escalate issues and develop and implement mitigation plans
• Facilitate internal CMC team meetings and meetings with LETI’s partners and CDMOs using meeting management best practices (both what and how) to drive cross-functional communication, timely and effective decision-making, and successful execution of program activities
• Coordinate updates / communications into CMC and R&D program governance forums, the S&OP process and periodic portfolio reviews
• Support the standardization of processes and communication(s) to build efficiencies within the ElevateBio ecosystem
• Proactively seek out opportunities for organizational and operational improvement, influencing within CMC Program Management for change (e.g. team structure, processes, communication, etc.)

Requirements:

• Bachelor’s Degree in a Life Science or Engineering discipline required. Advanced degree (MS or PhD) in Life Sciences or Engineering is preferred.
• 2+ years of CMC Program Management experience in biomedical industry. Cell/gene therapy preferred.
• 5+ years of experience working with biologics for human use in a biotech or pharmaceutical environment, specifically: GMP manufacturing; process development, characterization and validation; analytical method characterization and validation; and regulatory submissions for early development through commercialization
• 1-2+ years of experience working with FDA- and/or EU-regulated Quality systems
• Experience working with project management tools such as MS Project, MS Teams, MS Excel or Think-Cell; Smartsheet experience a bonus
• Strong communication skills with ability to build professional relationships with external and internal stakeholders a must
• SAP experience or similar ERP system is preferred
• Attention to detail and accuracy with respect to internal and external reporting
• Strong business acumen
• PMP® certification preferred
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred

We’re committed to finding the best ways to support our teams so they can do their best work. We take care of our employees, right from the start.

Health & Wellness

• Medical, vision, and dental insurance covered at 90%
• Low deductible, no co-insurance and no copays for mental health visits (for in-network care)
• Annual fitness reimbursement
• Employer paid for access to wellness apps and programs like Task Human

Financial

• Competitive compensation
• 401(k) retirement plans with a 4% employer match and no vesting period
• Employer-paid life insurance and short- and long-term disability insurance
• Employer-sponsored flexible spending accounts (FSA) and dependent care account (DCA)
• Access to a 1-on-1 financial advisor
• Commuter reimbursement benefit
• Monthly cell phone stipend

Time Off & Flexibility

• Unlimited paid time off, including vacation, sick leave, family leave, personal days, and bereavement
• 18 paid company holidays, plus an end-of-year holiday shut down
• 12 weeks of parental leave
• Federal Family and Medical Leave Act (FMLA) and Massachusetts Paid Family and Medical Leave (PFML), administered by Unum

Development Journey

• Insights Discovery training for every employee to make the most of workplace relationships
• Ongoing professional development, including manager training
• Access to LinkedIn Learning, a self-guided online education platform