About The Role:
The Operations Planner is responsible for developing, maintaining, and optimizing integrated production schedules to support gene therapy manufacturing operations. This role ensures alignment across Clinical and Commercial GMP Manufacturing, Supply Chain, Quality, Plasmids, Process Development, Sales, Finance, and Program Management while balancing capacity constraints, material availability, and regulatory requirements in a highly controlled, yet constantly evolving, environment.
Responsibilities:
- Develop and manage master production schedules (MPS) for gene therapy manufacturing and corresponding support activities.
- Translate clinical and commercial demand forecasts into feasible manufacturing plans considering cleanroom capacity, equipment availability, labor, and campaign strategies.
- Coordinate closely with Manufacturing, Quality, Supply Chain, MSAT, and Project Management to ensure schedule adherence and rapid issue resolution.
- Monitor material readiness (critical raw materials, single-use components, vectors, etc) and proactively identify supply risks impacting production timelines.
- Lead short- and long-range capacity planning to support pipeline growth, tech transfers, and scale-up activitiesin order to advise the Commercial team on available openings for new clients
- Manage and communicate schedule changes driven by deviations, investigations, equipment downtime, resource limitations, or other applicaple constraints.
- Analyze planning performance metrics (e.g., schedule adherence, capacity utilization, on-time delivery, days of supply, inventory turns, etc) and drive continuous improvement initiatives.
- Maintain accurate planning data within ERP/MRP systems (Netsuite, SmartSheets, PowerBI and customized excel tools).
- Create process appropriate SOPs and Work Instructions, as it relates to planning accountabilities and update existing documentation, with a Continuos Improvement mindset.
- Participate in S&OP / IBP processes, scenario modeling, and risk mitigation planning.
- Listens attentively to internal departments and team members to relay information, responsibilities, and policies respectfully, effectively, and clearly
Qualifications:
- Bachelor’s degree in Supply Chain, Operations Management, Life Sciences, or related field
- 3+ years of experience in Operations Planning, Production Planning, or Materials Planning within a manufacturing facility
- Strong understanding of manufacturing environments and regulated production workflows
- Comfortable in a fast paced and ever changing organization, where ambiguity of process exists
- Experience planning complex, multi-step processes with long lead times and constrained capacity
- Proficiency with ERP/MRP systems and advanced Excel or equivalent planning tools
- Strong analytical, communication, and cross-functional collaboration skills
- Commited to working in a team environment and supporting business in a respectful manner
Preferred Skills:
- Experience in cell and gene therapy, viral vectors (AAV, lentivirus), or similar manufacturing
- Familiarity with patient-specific or small-batch manufacturing models
- APICS certification (CPIM / CSCP) or similar
- Experience with capacity modeling and scenario planning tools
_This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned._
