NPI Manufacturing Specialist - Onsite

AGW; Thousand Oaks (CA); Sur place; USD 32 000 - 52 000; Plein temps

Avantages offerts par ce poste

Medical

Vision

Sick Pay

Résumé du poste

Aptask Global Workforce (AGW) is seeking a Specialist Manufacturing, New Product Introduction for an onsite, 6+ month contract in Thousand Oaks, CA. You will lead the introduction of new products into the drug product manufacturing plant and serve as a key interface among Manufacturing, Process Development, Quality, and Facilities & Engineering.

The role requires strong project planning, regulatory awareness, and excellent cross-functional communication to drive technology transfer timelines,

Qualifications

• Doctorate degree or Master's with 2+ years OR Bachelor's with 4+ years OR Associate's with 8 years OR high school with 10 years of experience.
• Knowledge of DP technical process, manufacturing operations, scientific method, and basic regulatory compliance expectations.
• Quantitative and analytical troubleshooting skills.
• Organized, cross-functional relationship builder.
• Able to articulate and communicate problem statements clearly, with a quality-first mindset.

Responsabilités

• Develop, maintain, and implement the NPI project plan(s), accountable for scope, schedule, risk management, and leading matrixed teams.
• Resolve issues in a timely manner and elevate cross-functional customer concerns to management as appropriate.
• Own Change Controls in Trackwise, ensuring records are compliant per GMP regulatory procedures.
• Proactively lead cross-functional team meetings to ensure NPI projects execute per schedule.
• Communicate verbally, in writing, and through presentations to peers and senior leadership.
• Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and with agency submissions.
• Hold supporting functions accountable for delivery of NPI project tasks.
• Review protocols for manufacturing activities and partner with Quality Assurance to ensure GMP standards are maintained.
• Identify and implement improvement opportunities within the organization.
• Perform Gemba walks in the manufacturing plant to identify process improvement opportunities.
• Report on team and plant metrics to ensure visibility to team operations and deliverables.
• Represent the team at plant-wide and network-wide forums as needed.

Connaissances

DP technical process

Manufacturing operations

Scientific method

Regulatory compliance expectations

Quantitative troubleshooting

Organized cross-functional

Clear problem statements

Formation

Doctorate degree

Master's degree + 2+ years

Bachelor's degree + 4+ years

Associate's degree + 8+ years

High school diploma / GED + 10 years

Description du poste

Aptask Global Workforce (AGW) is seeking a Specialist Manufacturing, New Product Introduction for an onsite, 6+ month contract in Thousand Oaks, CA. You will lead the introduction of new products into the drug product manufacturing plant and serve as a key interface among Manufacturing, Process Development, Quality, and Facilities & Engineering.

The role requires strong project planning, regulatory awareness, and excellent cross-functional communication to drive technology transfer timelines,