Senior Manager / Associate Director, CMC Project Management - Process Development & Validation
Artiva Biotherapeutics
June 29, 2026
Remote friendly (San Diego, CA)
United States
Operations
Job Summary:
- Lead planning and execution of process characterization and Process Performance Qualification (PPQ) workstreams; own detailed timelines, deliverables, and day-to-day coordination to meet validation and manufacturing readiness milestones.
Responsibilities:
- Own end-to-end project management of process characterization, PPQ, and commercial readiness workstreams (planning, sequencing, execution tracking).
- Develop and maintain bottoms-up workstream timelines and resource planning; integrate into the overall CMC schedule.
- Translate strategy into actionable execution plans, milestones, and deliverable trackers.
- Coordinate functional contributors (Technical Operations; internal/external partners such as CDMOs/CROs) to keep deliverables on track.
- Track dependencies for PPQ readiness activities (supplier/raw material qualification; equipment/facility qualification) and align with campaign timelines.
- Identify risks and issues within process characterization/PPQ (validation, batch execution, documentation, CDMO readiness); develop mitigation options and escalate with context.
- Track progress for study execution, engineering and PPQ batch manufacturing, release, stability, and validation activities.
- Build dashboards/trackers/status reports; provide workstream updates into CMC governance.
- Maintain repeatable tools, trackers, and best practices; improve execution rigor and efficiency.
Requirements:
- Bachelor’s degree in life sciences or related field (advanced degree preferred).
- 6–10+ years in biotechnology or pharmaceutical development.
- Experience supporting/leading process characterization, process validation, and/or PPQ.
- Strong understanding of GMP manufacturing, CDMO operations, and validation/regulatory expectations.
- Ability to manage detailed cross-functional workstreams with external partners (e.g., CDMOs).
- Ability to manage competing priorities.
Preferred:
- Hands-on PPQ or process validation execution.
- Familiarity with regulatory filings (IND/BLA/MAA) and CMC/validation content.
- PMP or similar certification (plus).
- Small to mid-size biotech experience.
Benefits:
- Medical, Dental, Vision; Group Life Insurance; LTD; 401(k); EAP; FSA; Paid Time Off; company paid holidays; Bonus.ly recognition program.
- Lead planning and execution of process characterization and Process Performance Qualification (PPQ) workstreams; own detailed timelines, deliverables, and day-to-day coordination to meet validation and manufacturing readiness milestones.
Responsibilities:
- Own end-to-end project management of process characterization, PPQ, and commercial readiness workstreams (planning, sequencing, execution tracking).
- Develop and maintain bottoms-up workstream timelines and resource planning; integrate into the overall CMC schedule.
- Translate strategy into actionable execution plans, milestones, and deliverable trackers.
- Coordinate functional contributors (Technical Operations; internal/external partners such as CDMOs/CROs) to keep deliverables on track.
- Track dependencies for PPQ readiness activities (supplier/raw material qualification; equipment/facility qualification) and align with campaign timelines.
- Identify risks and issues within process characterization/PPQ (validation, batch execution, documentation, CDMO readiness); develop mitigation options and escalate with context.
- Track progress for study execution, engineering and PPQ batch manufacturing, release, stability, and validation activities.
- Build dashboards/trackers/status reports; provide workstream updates into CMC governance.
- Maintain repeatable tools, trackers, and best practices; improve execution rigor and efficiency.
Requirements:
- Bachelor’s degree in life sciences or related field (advanced degree preferred).
- 6–10+ years in biotechnology or pharmaceutical development.
- Experience supporting/leading process characterization, process validation, and/or PPQ.
- Strong understanding of GMP manufacturing, CDMO operations, and validation/regulatory expectations.
- Ability to manage detailed cross-functional workstreams with external partners (e.g., CDMOs).
- Ability to manage competing priorities.
Preferred:
- Hands-on PPQ or process validation execution.
- Familiarity with regulatory filings (IND/BLA/MAA) and CMC/validation content.
- PMP or similar certification (plus).
- Small to mid-size biotech experience.
Benefits:
- Medical, Dental, Vision; Group Life Insurance; LTD; 401(k); EAP; FSA; Paid Time Off; company paid holidays; Bonus.ly recognition program.