Associate Manager, CMC Operations

CRISPR Therapeutics•South Boston, MA

2d•Hybrid

About The Position

The Associate Manager, CMC Operations supports the CMC Lead across multiple concurrent drug product development programs and external manufacturing operations. This role drives cross-program planning, coordination, and execution tracking — managing integrated timelines, risk and action logs, and cross-functional deliverables — so that CMC, Regulatory, QA, and CDMO partners stay aligned and program milestones are met. This is a hands-on operations role, not a purely administrative one: the person in this role will need to understand CMC and manufacturing context well enough to flag risks proactively, not just track tasks.

Requirements

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.
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.

Nice To Haves

Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
Collaborative – Openness, One Team
Undaunted – Fearless, Can-do attitude
Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
Entrepreneurial Spirit – Proactive. Ownership mindset.

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.
Partner with the CMC Lead to prioritize work across programs based on regulatory milestones and business impact.