NPI Manufacturing Specialist

Techtrueup•Thousand Oaks, CA

7d•Onsite

About The Position

We are seeking a Specialist Manufacturing to serve as a New Product Introduction (NPI) Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at a Drug Product (DP) manufacturing facility. The NPI Lead will own Technology Transfer Project Planning, an activity vital to the site's ability to support a clinical and commercial product mix across the broader manufacturing network. This role functions as the site interface between the network (e.g., Operations Strategy & Business Resilience, Product Delivery Teams) and site functions including Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interaction and collaboration is required across these groups, and the NPI Lead must understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines. Candidates will need to demonstrate knowledge of DP technical processes, 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 communication, both within and outside of the immediate team.

Requirements

Doctorate degree; OR
Master's degree in Engineering, Biology, Chemistry, or a Life Science field with 2+ years of directly related GMP manufacturing experience; OR
Bachelor's degree in Engineering, Biology, Chemistry, or a Life Science field with 4+ years of directly related GMP manufacturing experience; OR
Associate's degree with 8+ years of directly related GMP manufacturing experience; OR
High school diploma/GED with 10+ years of directly related GMP manufacturing experience.
Knowledge of DP technical processes, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative/analytical troubleshooting skills.

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 quality systems including change control, deviations, corrective and preventive actions, and/or validation practices.
Strong organizational and technical writing skills; able to articulate complex problems concisely to technical and management staff.
Independent, self-motivated, and able to multi-task in a fast-paced environment.
Team player with demonstrated flexibility and ability to manage change.
Direct experience in regulated environments (e.g., cGMP).

Responsibilities

Work with NPI support groups to develop, maintain, and implement the NPI project plan(s), owning scope, schedule, and risk management, and leading matrixed teams through influence to meet project milestones.
Lead cross-functional business cases to ensure the plant operates according to its long-term strategy through a sustainable pace of new commercial product introductions.
Resolve issues in a timely manner and elevate cross-functional concerns to various levels of management as appropriate.
Own Change Controls within the site's electronic quality management system, ensuring records are comprehensive and compliant per GMP regulatory procedures, using a Right-First-Time approach.
Proactively lead cross-functional team meetings to ensure NPI project(s) and other relevant business cases execute per schedule.
Succinctly communicate verbally, in writing, and through presentations to peers and senior leadership.
Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and with agency submissions while delivering NPI project(s).
Hold supporting functions accountable for delivery of NPI project tasks through documentation of lessons learned and presentation to management when appropriate.
Review protocols for manufacturing activities and partner with Quality Assurance to ensure GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
Identify improvement opportunities within the organization and take proactive steps to build consensus to implement them.
Perform purposeful presence (Gemba) walks in the manufacturing plant to identify process improvement opportunities related to NPIs and lifecycle management strategies.
Report on team and plant metrics to ensure visibility into team operations and deliverables.
Represent the team at plant-wide and network-wide forums, as needed.