Associate Manager, CMC Operations
CRISPR Therapeutics, Inc. · Remote, Massachusetts, United States
About The Role
Company Overview
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. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals . CRISPR Therapeutics AG is headquartered in Zug, Switzerland , with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California .
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.
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
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.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
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