Specialist Manufacturing

Job Title: Specialist Manufacturing New Product Introduction Job Description This Specialist Manufacturing New Product Introduction role focuses on leading new product introduction (NPI) activities within a regulated, cGMP manufacturing environment. You drive NPI project planning and execution, coordinate cross-functional teams, and ensure all activities comply with GMP and regulatory requirements. The role is fully onsite, aligned with standard business hours, and requires strong project management, communication, and problem-solving skills with a quality-first mindset. Responsibilities Develop, maintain, and implement comprehensive NPI project plans, taking accountability for project scope, schedule, and risk management. Lead matrixed, cross-functional teams through influence to achieve NPI project milestones and deliverables. Resolve project and operational issues in a timely manner, escalating cross-functional concerns to appropriate levels of leadership when needed. Own and manage change controls in Trackwise, ensuring records are complete, accurate, and compliant with GMP regulatory procedures using a Right-First-Time approach. Proactively lead cross-functional team meetings to ensure NPI projects and related business cases execute according to schedule. Communicate succinctly and clearly, verbally, in writing, and through presentations to peers and leadership. Engage closely with Quality and Regulatory teams to ensure alignment, compliance across the network, and support for regulatory agency submissions during NPI delivery. Hold supporting functions accountable for completing NPI project tasks, documenting lessons learned, and presenting key findings to management when appropriate. Review protocols for manufacturing activities and partner with Quality Assurance to ensure GMP standards are maintained in accordance with current SOPs, batch record documentation, and licenses. Identify improvement opportunities within the organization and take proactive steps to build consensus and implement agreed changes. Conduct purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities related to NPIs and lifecycle management strategies. Monitor and report on team and plant metrics to provide visibility into operations and key deliverables. Represent the NPI team at plant-wide and network-wide forums as needed, acting as a key liaison for manufacturing initiatives. Essential Skills Strong project management capabilities, including planning, scheduling, and risk management for complex cross-functional initiatives. Ability to build and maintain effective cross-functional relationships and lead matrixed teams through influence. Excellent communication skills, able to articulate and communicate problem statements clearly to technical staff and management. Quality-first mindset with a commitment to GMP compliance and Right-First-Time execution. Independent problem-solving skills, with the ability to work autonomously and make sound decisions in a fast-paced environment. Strong organizational skills and attention to detail in managing documentation, change controls, and project deliverables. Technical writing skills, able to present complex issues and solutions concisely and clearly. Experience working in regulated environments such as cGMP manufacturing. Ability to manage change and demonstrate flexibility in response to evolving project and business needs. Collaborative, team-oriented approach with the ability to hold stakeholders accountable while maintaining positive working relationships. Additional Skills & Qualifications Prior project management experience in a manufacturing or regulated environment. Direct and/or indirect people management and leadership experience. Understanding of drug product formulation and vial or syringe filling operations. Experience with quality systems, including change control, deviations, corrective and preventive actions (CAPA), and validation practices. Demonstrated ability to multi-task and prioritize work effectively in a fast-paced setting. Experience performing Gemba walks or similar continuous improvement activities in manufacturing. Comfort presenting lessons learned, metrics, and project updates to leadership and cross-functional forums. Track record of clear, concise communication without convoluted messaging. Work Environment This is a 100% onsite role supporting standard business hours, Monday through Friday, 8:00 a.m. to 5:00 p.m. PST. You work primarily within a cGMP-regulated manufacturing plant and office environment, collaborating closely with operations, quality, regulatory, and other support functions. The role involves regular presence on the production floor, including Gemba walks to observe processes and identify improvement opportunities. You use established quality systems such as Trackwise for change control and work with SOPs, batch records, and regulatory documentation. The environment is fast-paced, highly cross-functional, and focused on continuous improvement, operational excellence, and strict adherence to GMP and regulatory standards. Job Type & Location This is a Contract position based out of Thousand Oaks, CA. Pay and Benefits The pay range for this position is $40.00 - $40.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) San Francisco Fair Chance Ordinance Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI) We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Equal Opportunity Statement The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Accommodation Request If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. #J-18808-Ljbffr Actalent