Aptask Global Workforce (AGW) is seeking a Specialist Manufacturing, New Product Introduction for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 6+ month contract opportunity. 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 role serves as a New Product Introduction Lead and will function as a vital interface between Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interaction and collaboration is required to drive decision-making and manage timelines for technology transfer projects.
Responsibilities: - Work 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
- Resolve issues in a timely manner and elevate cross-functional customer concerns to various levels of management as appropriate
- Own Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures
- Proactively lead cross-functional team meetings to ensure NPI project(s) execute per schedule
- Succinctly 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 various agency submissions
- Hold supporting functions accountable for delivery of NPI project tasks
- Review protocols for manufacturing activities and partner with Quality Assurance to ensure that GMP standards are maintained
- Identify and implement improvement opportunities within the organization
- Perform purposeful presence 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
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
- 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
- Independent problem solver
Desired 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, and corrective and preventative actions
- Strong organization and technical writing skills
- Independent, self-motivated, and able to multi-task in a fast-paced environment
- Direct experience with regulated environments (e.g., cGMP)
Pay range: up to $38.46 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
