Specialist Manufacturing

Job Title: Specialist Manufacturing - New Product Introduction (NPI) Location: Thousand Oaks, CA Schedule: Monday-Friday, 8 AM - 5 PM PST Duration: 12 Months (Potential for Extension) Position Summary The Specialist Manufacturing, New Product Introduction (NPI) role is a critical position within the Thousand Oaks Drug Product (DP) facility (ATO B20). This individual will lead and manage the introduction of new products into the manufacturing plant, functioning at the intersection of Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering . The NPI Lead will own technology transfer project planning, drive cross-functional alignment, influence key stakeholders, and ensure successful delivery of NPI milestones while maintaining compliance with GMP standards. Key Responsibilities Lead development, maintenance, and execution of NPI project plans, ensuring scope, timelines, risks, and deliverables are aligned. Drive matrixed teams through influence to meet project milestones and escalate issues appropriately. Own Change Controls in TrackWise with a strict Right-First-Time approach, ensuring GMP-compliant documentation. Lead cross-functional team meetings to ensure NPI projects progress per schedule. Communicate clearly and effectively through verbal updates, written summaries, and presentations to peers and senior leadership. Collaborate with Quality and Regulatory teams to ensure compliance with GMP standards and regulatory submissions. Track lessons learned and hold supporting functions accountable for deliverables. Review manufacturing protocols and partner with Quality Assurance to maintain compliance with SOPs, batch records, and licenses. Identify and drive process improvement opportunities across manufacturing and lifecycle management. Perform purposeful Gemba walks to identify optimization opportunities related to NPI activities. Track and report team and plant metrics for operational visibility. Represent the team in plant-wide and network-wide forums as needed. Basic Qualifications Candidates must meet one of the following criteria: Doctorate degree OR Master's degree + 2 years of experience OR Bachelor's degree + 4 years of experience OR Associate degree + 8 years of experience OR High school diploma/GED + 10 years of experience Preferred Qualifications Project management experience Direct or indirect people leadership experience Knowledge of Drug Product Formulation and Vial/Syringe Filling operations Experience with GMP quality systems (change control, deviations, CAPA, validation) Strong organizational and technical writing skills Ability to manage multiple priorities in a fast-paced environment Strong communication and collaboration skills Demonstrated flexibility and adaptability Experience working in regulated environments (e.g., cGMP) Top 3 Must-Have Skill Sets Cross-functional project management experience Change control experience in a GMP environment Strong independent problem-solving ability Additional Must-Have: Drug Product Manufacturing experience Day-to-Day Responsibilities Manage tech transfer projects and own associated change controls Lead multiple tech transfers in parallel and report progress to management Update and maintain metrics related to tech transfer status Resolve issues independently and filter escalations appropriately Employee Value Proposition Opportunity to gain valuable Client experience Work in a high-impact, cross-functional environment supporting the introduction of new drug products Red Flags No prior tech transfer or change control experience No GMP-based change management experience Interview Process Up to 3 virtual/video interviews

Created: 2026-04-05