Hybrid Associate Manager, CMC Operations

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

Job summary

CRISPR Therapeutics, Inc. is seeking an Associate Manager, CMC Operations to support cross-program planning and execution across drug product development and external manufacturing.

This hands-on role drives timelines, risk logs, and deliverables with CMC, Regulatory, QA, and CDMO partners. The ideal candidate has 5–7+ years in CMC or biologics environments, with strong project management skills and experience using Smartsheet or MS Project.

Qualifications

• Bachelor's degree in a scientific, engineering, or related field; 5-7+ years of relevant experience, or advanced degree with 4-6 years.
• Experience supporting biologics, cell/gene therapy, or LNP-based drug products.
• Familiarity with multi-program tracking tools (Smartsheet, MS Project, or similar).

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 elevate 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.
• Partner with the CMC Lead to prioritize work across programs based on regulatory milestones and business impact.
• Project/timeline management experience in a CMC, drug substance/drug product, or biologics environment, with skill in cross-program plans, risk logs, and action trackers.
• Working fluency in CMC/manufacturing terminology (tech transfer, batch records, GMP milestones, CDMO interactions) to flag risk, not just log tasks.
• Strong cross-functional communication skills to drive accountability across CMC, Regulatory, QA, and CDMO partners without formal authority.

Skills

Biologics/Cell therapy background

Cross-functional collaboration

Project/timeline management

Attention to detail with big picture

Education

Bachelor's degree in science/engineering or related field

5-7+ years of relevant experience (or 4-6 with advanced degree)

Tools

Smartsheet

MS Project

Job description

CRISPR Therapeutics, Inc. is seeking an Associate Manager, CMC Operations to support cross-program planning and execution across drug product development and external manufacturing.

This hands-on role drives timelines, risk logs, and deliverables with CMC, Regulatory, QA, and CDMO partners. The ideal candidate has 5–7+ years in CMC or biologics environments, with strong project management skills and experience using Smartsheet or MS Project.