Specialist Manufacturing

GTT•Thousand Oaks, CA

1d•Onsite

About The Position

This role is a New Product Introduction (NPI) Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at the Thousand Oaks Drug Product (DP) facility — also known as ATO B20. In this critical role, you will be responsible for the introduction of new products into the manufacturing plant. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20, with a clinical and commercial product mix, has on the broader network. This role will function as a vital interface between the five key functions that enable the B20 plant to add value to the network: 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 needs to be able to 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 effective communication, both within and outside of the immediate team.

Requirements

Organized, detail oriented
Independent problem solver
Project manager able to influence other teams indirectly and impose timelines
Minimum experience requirements vary by degree level (see Education Requirements above): 2 years with a Master's degree, 4 years with a Bachelor's degree, 8 years with an Associate's degree, or 10 years with a high school diploma/GED.

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
Team-player
Demonstrated flexibility and ability to manage change
Direct experience with regulated environments (e.g., cGMP, etc.)

Responsibilities

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 promptly and elevating cross-functional customer concerns 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 related 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.
Using team templates and tools, develop NPI timelines to deliver products into the B20 DP manufacturing facility, hosting meetings with stakeholders to resolve timeline discrepancies when necessary.
When leading the NPI projects, enter change control documentation into the quality system with a right-first-time approach, using a high standard of technical writing.
Keep track of material numbers and provide regular status updates to management, identifying concerns/weak signals and elevating when needed.