Associate Manager, CMC Operations
About the Company
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.
CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine, and rare diseases. The company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals, and is headquartered in Zug, Switzerland, with U.S. R&D operations based in Boston, Massachusetts, and San Francisco, California.
About the Role
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 requiring an understanding of CMC and manufacturing context to proactively flag risks, 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.
Requirements
- Bachelor's degree in a scientific, engineering, or related technical field; advanced degree a plus.
- 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.
- 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.
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.
Work Environment
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Employees work at least three days on-site, creating a collaborative environment that cultivates mentorship opportunities, increases cross-functional communication, and offers opportunities for connection. Certain lab-based and manufacturing positions are fully on-site.
Pay
Base pay range of $110,000 to $120,000, plus bonus, equity, and benefits.