Associate Manager, CMC Operations
Indexed description
Position Summary
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.
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.
- 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.
- 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.
Associate Manager, CMC Operations: Base pay range of $110,000 to $120,000+ bonus, equity and benefits
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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