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 12+ month contract opportunity. In this critical role for the 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, functioning as a vital interface between Manufacturing, Process Development, Supply Chain, Quality, and Engineering. The position requires ownership over Technology Transfer Project Planning to support a clinical and commercial product mix.
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 through influence to meet NPI project milestones
- Resolve issues in a timely manner and elevate cross-functional customer concern 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) and other relevant business cases execute per schedule
- Succinctly communicate verbally, in writing, and through presentations to peers and senior leadership team
- Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s)
- Review protocols for manufacturing activities and partner with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses
- Identify improvement opportunities within the organization and take proactive steps to build consensus to implement those opportunities
- Perform purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies
- 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 Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
- Knowledge of Drug Product (DP) technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative/analytical troubleshooting skills
- Organized, detail-oriented, and an independent problem solver
- Project manager able to influence other teams indirectly and impose timelines
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, 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
- Demonstrated flexibility and ability to manage change
- Direct experience with regulated environments (e.g., cGMP etc.)
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.
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