Job Summary:
We are seeking an experienced CMC Project Management professional to lead the planning and execution of our process characterization and Process Performance Qualification (PPQ) workstreams. This role owns the detailed timelines, deliverables, and day-to-day coordination required to advance these specific workstreams from strategy through execution, ensuring validation and manufacturing readiness milestones are met.
This is a hands-on, execution-focused role. The successful candidate will drive the operational rhythm within the process characterization and PPQ workstreams-managing schedules, tracking deliverables, surfacing risks early, and keeping contributing functions and external partners aligned on what is due and when. Workstream status and key decisions feed into the broader CMC project management framework, partnering closely with the CMC project lead and other workstream owners to maintain overall program alignment.
Duties/Responsibilities:
- BLA and Commercial-Readiness
- Own end-to-end project management of the process characterization, PPQ, and Commercial readiness workstreams including planning, sequencing, and execution tracking through to completion
- Develop and maintain detailed, bottoms-up workstream timelines and resource planning for process characterization, validation activities, and PPQ campaigns, and ensure they integrate cleanly into the overall CMC program schedule
- Translate the strategy into actionable execution plans, milestones, and deliverable trackers
- Coordinate the functional contributors to these workstreams-including Technical Operations, internal, and external partners (CDMOs, CROs))-to keep deliverables on track
- Coordinate with adjacent PPQ readiness activities - including supplier and raw material qualification and equipment/facility qualification - tracking them as dependencies and ensuring alignment with campaign timelines
- Drive alignment on assumptions, deliverables, and timelines specific to process characterization and PPQ execution
- Provide clear, structured workstream updates and supporting analysis into existing CMC program governance and decision forums
- Risk & Issue Management (Workstream Level)
- Proactively identify risks within the process characterization and PPQ workstreams-including validation, batch execution, documentation, and CDMO readiness risks
- Develop mitigation options and escalate workstream-level issues with appropriate context and recommended paths forward
- Track dependencies that could affect PPQ timing or downstream regulatory and clinical supply needs, and flag them to the CMC project lead for cross-program visibility
- Track progress against process characterization and PPQ deliverables, including study execution, engineering and PPQ batch manufacturing, release, stability, and validation activities
- Drive PPQ campaign readiness, including coordination of protocols, batch records, documentation, and quality system prerequisites
- Monitor CDMO execution against process characterization and PPQ plans and ensure alignment with workstream expectations
- Reporting & Workstream Communication
- Build and maintain dashboards, trackers, and status reports for the process characterization and PPQ workstreams, providing clear visibility into progress, milestones, and risks
- Report workstream status, key risks, and decision points into existing CMC program governance and leadership forums on a regular cadence
- Translate detailed workstream data into concise, decision-ready summaries for the CMC project lead and senior stakeholders
- Maintain timely, structured communication with functional contributors and external partners to keep deliverables and timelines aligned
- Process & Continuous Improvement
- Develop and refine repeatable tools, trackers, and best practices for managing process characterization and PPQ readiness
- Identify opportunities to improve execution rigor and efficiency within the workstreams
Requirements
- Bachelor's degree in life sciences or related field (advanced degree preferred)
- 6-10+ years of experience in biotechnology or pharmaceutical development
- Demonstrated experience supporting or leading process characterization, process validation, and/or PPQ activities
- Strong understanding of GMP manufacturing, CDMO operations, and validation/regulatory expectations
- Proven ability to manage detailed, cross-functional workstreams with multiple contributors and external partners
- Experience working with external partners (e.g., CDMOs)
- Ability to manage competing priorities and other tasks as needed
Preferred
- Direct hands-on experience executing PPQ campaigns or process validation programs
- Familiarity with regulatory filings (IND/BLA/MAA) and the CMC/validation content they require
- PMP or similar project management certification (a plus, not required)
- Small to mid-size Biotech company experience
Core Competencies
- Execution-focused, with the ability to drive detailed plans to completion
- Effective in a fast-paced, evolving environment
- Strong collaboration and influencing skills; works well as part of a broader CMC project team without requiring direct authority
- Excellent communication skills, including the ability to translate complex technical topics for diverse audiences
- Proactive, solutions-oriented mindset with strong attention to detail
In addition to a great culture, we offer:
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
Base Salary: $155,000 - 190,000. Exact compensation may vary based on level, skills and experience.
