Specialist Manufacturing - NPI

Specialist Manufacturing - NPI

Location: Thousand Oaks, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 6 months
• Pay Rate: $32.00–$38.00 / Hour (USD)
• Shift / Schedule: Standard business hours, Monday–Friday, 8:00 AM – 5:00 PM PST
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

You've worked hard to become the professional you are today and are now ready to take the next step in your career. At this leading biotechnology company, a shared mission — to serve patients — drives all that is done, and it is key to becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide.

In this critical role for the Thousand Oaks Drug Product (DP) facility — also known as ATO B20 — you will be responsible for the introduction of new products into the manufacturing plant. ThisSpecialist Manufacturing role will serve as a New Product Introduction (NPI) Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20. 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 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.

Key Responsibilities

Primary 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 the senior leadership team.

Additional Responsibilities:

• 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 pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility into team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.

Day-to-Day Responsibilities:

• Lead cross-functional team meetings, be able to listen to problem statements and ask questions to understand root causes and next steps.
• Own GDP documents in the quality management system and operate with a right-first-time, quality-first approach.

Required Skills

• Organized, cross-functional relationship builder
• Able to articulate and communicate problem statements clearly, with a quality-first mindset
• Independent problem solver

Preferred Skills

• 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 multitask in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP, etc.)

Education Requirements

• Doctorate degree
• OR Master's degree and 2 years of experience
• OR Bachelor's degree and 4 years of experience
• OR Associate's degree and 8 years of experience
• OR High school diploma / GED and 10 years of experience

Important Notes

• Interview process: Video interview via MS Teams.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-16307Industry: Manufacturing & Operations

#LI-Onsite #gttic #gttmf