New Product Introduction Lead

Responsibilities

• Working with NPI support groups (e.g. PD, Manufacturing, F&E, QA) to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolving issues in a timely manner (i.e. drive Root Cause Analyses) and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Owning NPI record documents in CDOCS (Veeva system)
• Proactively leading cross-functional team meetings, to ensure NPI project(s) execute per schedule

Additional Responsibilities

• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.

Qualifications

• Basic Qualifications:
• Masters degree in Engineering, Biology, Chemistry or Life Science Field OR
• Bachelors degree in Engineering, Biology, Chemistry or Life Science Field and 6 months of biotechnology operations experience OR
• Associates degree and 2 years of biotechnology operations experience OR
• High school diploma / GED and 4 years of biotechnology operations experience
• Preferred Qualifications:
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff of varying organizational levels in both presentation and technical writing forms
• Project Management Experience
• Understanding of/Experience in Drug Product Formulation and Vial/Syringe Filling operations in a GMP environment
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

Full time