Specialist Manufacturing #26-19133

US Tech Solutions, Inc.

Thousand Oaks, CA
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Skills

Analysis Skillsunmatched
Business Caseunmatched
Business Processesunmatched
Change Controlunmatched
Change Managementunmatched
Communication Skillsunmatched
Corrective Actionunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Document Managementunmatched
Documentationunmatched
Drug Productsunmatched
Facilities Engineeringunmatched
GMP (Good Manufacturing Practices)unmatched
High School Diplomaunmatched
Identify Issuesunmatched
Leadershipunmatched
Maintain Complianceunmatched
Management Strategyunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
Manufacturing Operationsunmatched
Manufacturing/Industrial Processesunmatched
Materials Trackingunmatched
Medical Productsunmatched
Metricsunmatched
Multitaskingunmatched
Organizational Skillsunmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Process Improvementunmatched
Process Manufacturingunmatched
Product/Service Launchunmatched
Project Planningunmatched
Project/Program Managementunmatched
Quality Assuranceunmatched
Quantitative Analysisunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Risk Managementunmatched
Scientific Methodunmatched
Standard Operating Procedures (SOP)unmatched
Supply Chainunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Technical Leadershipunmatched
Technical Writingunmatched
Time Managementunmatched
Writing Skillsunmatched

Description

Duration: 12 months contract
Shift hours : M-F 8-5pm PST

Job Summary:

In this critical role for the Thousand Oaks Drug Product (DP) facility, 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 Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team.
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that with a clinical and commercial product mix has to the network.
This role will function as a vital interface between the 5 key functions that enable the plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering.
A high degree of interactions 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.
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that with a clinical and commercial product mix has to the network.
This role will function as a vital interface between the 5 key functions that enable the plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions 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.

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.)

Top 3 Must Have Skill Sets:

Organized, detail oriented
Independent problem solver
Project manager able to influence other teams indirectly and impose timelines

Day to Day Responsibilities:

Using our team templates & tools, develop NPI timelines to deliver products into the manufacturing facility, hosting meetings with stakeholders to resolve timeline discrepancies when necessary.
When leading the NPI projects, be able to 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 be able to provide regular status updates to management, identifying concerns/weak signals and elevating when needed.

Basic Qualifications:

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

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

Numbers & Facts

Location

Thousand Oaks, CA

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