Job description

Target PR Range: 25-35/hr DOE Role: Specialist Manufacturing, New Product Introduction Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team. The NPI Lead will be primarily responsible for: * Working with NPI support groups 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 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. * Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule. * Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team. Additional Responsibilities include: * Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s). * Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate. * Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses. * 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. * Representing the team at plant-wide and network-wide forums, as needed. Preferred Qualifications: * Project Management experience * Direct and/or indirect people management / leadership experience * Understanding of Drug Product Formulation and Vial/Syringe Filling operations * Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices * Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff * 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.)

Requirements

Must-haves

Target PR Range: 25-35/hr DOE
Role: Specialist Manufacturing, New Product Introduction
The NPI Lead will be primarily responsible for:
Resolving issues in a timely manner 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.
Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
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.
Representing the team at plant-wide and network-wide forums, as needed.

Nice-to-haves

Project Management experience
Direct and/or indirect people management / leadership experience
Understanding of Drug Product Formulation and Vial/Syringe Filling operations
Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
Independent, self-motivated, able to multi-task in a fast-paced environment
Demonstrated flexibility and ability to manage change
Direct experience with regulated environments (e.g., cGMP etc.)

Application prep

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Platform: wp-job-manager
Effort: medium