Regulatory Operations Associate Jobs in Massachusetts

Job Description:

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis 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 Therapeuticsis 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 Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug,Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan 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