Job Description:Position SummaryThe 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.
Minimum 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.
Preferred Qualifications- Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
Competencies- 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.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Associate Manager, CMC Operations: Base pay range of $110,000 to $120,000+ bonus, equity and benefits
