Description:
Note:

• Remote - PST time zone preferred not required
• Flexibility in work hours is required, schedule is typically 8:00 AM to 5:00 PM schedule, with occasional early meetings to support global operations

Ideal candidate: 

• This role requires a technically skilled professional with at least five years of GMP experience, where hands-on expertise in manufacturing processes, particularly upstream in drug substance, is highly valued. While a scientific degree is preferred, practical experience in GMP environments and managing quality records takes priority. Strong team leadership and facilitation skills are essential for coordinating projects efficiently.

Description:

• Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
• Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
• Site performance monitoring: 
• Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
• Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

Basic Qualifications    

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:        

• 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• Quality Records: Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.

Pay Rate between $41 - $47/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"