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 This Specialist Manufacturing role focuses on New Product Introduction (NPI) and will serve as an NPI Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at the Thousand Oaks Drug Product (DP) facility (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 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.
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 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 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.
Day-to-Day Responsibilities:
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, 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. Required Skills Organized, detail oriented Independent problem solver Project manager able to influence other teams indirectly and impose timelines 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 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.) 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 Required Experience Minimum experience varies by degree level: 2 years (Master's), 4 years (Bachelor's), 8 years (Associate's), or 10 years (High school diploma / GED); no additional experience required at the Doctorate level. Benefits Medical, Vision, and Dental Insurance Plans 401k
Retirement Fund Important Notes Interview Process:
Video interviews, 2 3 rounds About the Client This pioneering biotechnology company has been at the forefront of using human biology to fight serious, life-altering illnesses for more than four decades, reaching millions of patients across more than 100 countries. The organization discovers, develops, manufactures, and delivers innovative medicines globally, focusing on areas including cardiovascular disease, oncology, bone health, inflammation, and neuroscience and with approximately 24,000 employees, it ranks among the world's largest independent biotechnology companies. What makes this organization distinctive is its commitment to scientific rigor combined with a genuine patient-first mission, reflected in a pipeline consistently regarded as one of the most robust and closely watched in biopharma. In 2024, employees voted this organization onto Glassdoor's Best Places to Work list, underscoring genuine workforce engagement. Teams here span research scientists, clinical development professionals, bioprocess engineers, and commercial operations specialists who benefit from world-class facilities, cutting-edge research platforms, and a breadth of career pathways across discovery, clinical operations, manufacturing, and commercial functions. 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.
