CMC Operations Lead — Biologics & Gene Therapy

Crispr-Therapeutics-1; Boston (MA); Hybrid; USD 110,000 - 120,000; Full time

Job summary

CRISPR Therapeutics in Boston, MA, seeks an Associate Manager, CMC Operations to drive cross-program planning across CMC activities, tech transfer, and manufacturing milestones. This role is hands-on and requires strong project management and cross-functional collaboration to flag risks and ensure alignment.

The successful candidate will coordinate with CMC, Regulatory, QA, and CDMO partners to meet milestones, track budgets, and maintain integrated timelines.

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical field; advanced degree a plus and 5-7+ years of relevant experience, or advanced degree and 4-6 years.
• Prior experience supporting biologics, cell/gene therapy, or LNP-based drug product programs.
• Familiarity with project management tools (e.g., Smartsheet, MS Project, or similar) for multi-program tracking.

Responsibilities

• Build and maintain integrated cross-program timelines spanning tech transfer, process development, manufacturing campaigns, and regulatory-supporting deliverables.
• Own program-level risk and action logs; proactively identify dependencies, conflicts, and timeline risks across the 3 active programs and escalate as needed.
• Coordinate deliverables and follow-through across CMC, Regulatory, QA, and external CDMO partners, driving accountability without formal authority over those groups.
• Track CDMO batch scheduling, tech transfer milestones, and manufacturing deliverables; flag scheduling conflicts or resourcing gaps early.
• Support budget, purchase order, and supply planning inputs relevant to external DP manufacturing activities.
• Prepare status reports, dashboards, and meeting materials for program and governance reviews; ensure meeting follow-through and documentation.

Skills

Cross-functional communication

Risk management

Program management

Timeline planning

Education

Bachelor's degree in science/engineering

Advanced degree a plus

Tools

Smartsheet

MS Project

Job description

CRISPR Therapeutics in Boston, MA, seeks an Associate Manager, CMC Operations to drive cross-program planning across CMC activities, tech transfer, and manufacturing milestones. This role is hands-on and requires strong project management and cross-functional collaboration to flag risks and ensure alignment.

The successful candidate will coordinate with CMC, Regulatory, QA, and CDMO partners to meet milestones, track budgets, and maintain integrated timelines.