Senior Manager – CMC Site Scheduling – Cell & Gene Therapy

Senior Manager – CMC Site Scheduling – Cell & Gene Therapy

Requirements

• 6+ years of experience in industry (GMP/pharmaceutical highly preferred).
• Expertise in predictive scheduling tools that allow for modeling, simulation, operator allocation and white space analysis. Experience using Real Time Modeling System (RTMS) or Primavera P6 preferred.
• Experience in understanding specific manufacturing process information as detailed in a master batch record (MBR).
• Demonstrated ability to work effectively in a collaborative, and fast-paced team environment, including influencing business leadership.
• Proven track record of driving change in a dynamic organization.
• Excellent interpersonal skills, verbal, and written communication skills.
• Highly skilled in data analysis, manipulation, and presentations, to include software skills with Microsoft Office – specifically Excel VBA, Power BI, Smartsheet and Asana.
• Knowledge of Oracle or related ERP systems.

Responsibilities

• Create, track, and maintain production schedule changes and progress in the planning application to provide visibility to all stakeholders to drive short- and long-term execution plans.
• Collaborate with CMC functional area leaders to ensure that the schedule is optimized.
• Define, measure, and communicate key performance indicators and supportive metrics that track the effectiveness of production planning and manufacturing execution.
• Lead SCRUM calls as needed with cross functional team members to align and facilitate discussions on manufacturing updates, quality events, harvest, and dosing schedules as well as facility operations.
• Liaise with Materials Management and Manufacturing to help prioritize raw materials that need to be received and released. Proactively follow-up on outstanding items.
• Check production readiness and material availability to enable execution of production schedule.
• Provide clinical target progress updates to primary stakeholders by utilizing the necessary software to track the internal path to release. Deliver weekly reports displaying dispositioning progress.
• Support with the implementation of any new Production Planning System along with other stakeholders.
• Serve as liaison between CMC, Clinical Operations and Global Medicines Development & Medical Affairs (GMDA) to align on T1D dosing strategy ensuring that operational and program goals are met.
• Ability to influence others and work independently and in a team environment.

Preferred Qualifications

No preferred qualifications provided.