Associate Manager, CMC Operations
CRISPR Therapeutics
August 10, 2026
Remote friendly (Boston, MA)
United States
Operations
Position Summary:
The Associate Manager, CMC Operations supports the CMC Lead across multiple concurrent drug product development programs and external manufacturing operations. Drives cross-program planning, coordination, and execution tracking so CMC, Regulatory, QA, and CDMO partners stay aligned and program milestones are met.
Responsibilities:
- Build and maintain integrated cross-program timelines (tech transfer, process development, manufacturing campaigns, regulatory-supporting deliverables).
- Own program-level risk and action logs; identify dependencies, conflicts, and timeline risks; escalate as needed.
- Coordinate deliverables and follow-through across CMC, Regulatory, QA, and external CDMO partners.
- Track CDMO batch scheduling, tech transfer milestones, and manufacturing deliverables; flag scheduling conflicts/resourcing gaps.
- Support budget, purchase order, and supply planning inputs for external DP manufacturing.
- Prepare status reports, dashboards, and meeting materials; ensure follow-through and documentation.
- Prioritize work across programs with the CMC Lead based on regulatory milestones and business impact.
Minimum Qualifications:
- Bachelor’s degree in scientific/engineering/related field; advanced degree a plus with 5–7+ years relevant experience (or advanced degree with 4–6 years).
- Experience supporting biologics, cell/gene therapy, or LNP-based drug product programs.
- Familiarity with project management tools (e.g., Smartsheet, MS Project).
Preferred Qualifications:
- Strong analytical, problem-solving, and critical thinking skills.
Compensation/Benefits:
- Base pay range of $110,000 to $120,000+ bonus, equity and benefits.
The Associate Manager, CMC Operations supports the CMC Lead across multiple concurrent drug product development programs and external manufacturing operations. Drives cross-program planning, coordination, and execution tracking so CMC, Regulatory, QA, and CDMO partners stay aligned and program milestones are met.
Responsibilities:
- Build and maintain integrated cross-program timelines (tech transfer, process development, manufacturing campaigns, regulatory-supporting deliverables).
- Own program-level risk and action logs; identify dependencies, conflicts, and timeline risks; escalate as needed.
- Coordinate deliverables and follow-through across CMC, Regulatory, QA, and external CDMO partners.
- Track CDMO batch scheduling, tech transfer milestones, and manufacturing deliverables; flag scheduling conflicts/resourcing gaps.
- Support budget, purchase order, and supply planning inputs for external DP manufacturing.
- Prepare status reports, dashboards, and meeting materials; ensure follow-through and documentation.
- Prioritize work across programs with the CMC Lead based on regulatory milestones and business impact.
Minimum Qualifications:
- Bachelor’s degree in scientific/engineering/related field; advanced degree a plus with 5–7+ years relevant experience (or advanced degree with 4–6 years).
- Experience supporting biologics, cell/gene therapy, or LNP-based drug product programs.
- Familiarity with project management tools (e.g., Smartsheet, MS Project).
Preferred Qualifications:
- Strong analytical, problem-solving, and critical thinking skills.
Compensation/Benefits:
- Base pay range of $110,000 to $120,000+ bonus, equity and benefits.