Specialist Manufacturing NPI

• Production Support Operator or Associate
• Manufacturing Specialist
• Production Support Manager
• Drug Specialist in a Manufacturing Environment

Thousand Oaks CA

Onsite

• Position Type: Contract
• Contract Duration: 6 months
• Pay Rate: $32.00$38.00 / Hour (USD)
• Shift / Schedule: MondayFriday 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.

Youve 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 organization a shared mission to serve patients drives all that is done key to becoming one of the worlds 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. This Specialist 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 network. This role will function as a vital interface between the 5 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.

Each product requires approximately 23 months of support with key responsibilities including maintaining control of project timelines and ensuring that the correct deliverables are completed for each product in collaboration with cross-functional stakeholders.

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.
• Leading cross-functional team meetings being able to listen to problem statements and ask questions to understand root causes and next steps.
• Owning GDP documents in the quality management system and operating with a right-first-time quality-first approach.

• Organized cross-functional relationship builder
• Able to articulate and communicate problem statements clearly with a quality-first mindset
• Independent problem solver
• A few years of project management experience
• Experience supporting continuous improvement projects
• Knowledge of GDP and GMP
• Strong team player
• Excellent communication 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.)
• Drug manufacturing background
• Experience with drug substance or drug packaging

• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

• Experience in a highly regulated industry is required preferably related to new product development or new product introduction.

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

• Interview process: Video interview via MS Teams.

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: 26-16307 Industry: Manufacturing & Operations

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