Immediate opportunity for a Manufacturing Specialist to provide information insight and data analysis, drive execution of transactional / tactical tasks to ensure performance execution across the external manufacturing network. The Manufacturing Specialist will work REMOTELY supporting one of the world's leading biotechnnology companies located in Thousand Oaks, CA.
Schedule/Shift: 1st shift, Mon.-Fri. Flexibility in work hours is required. Schedule is typically 8:00AM to 5:00PM PST, with occasional early meetings to support global operations.
Position type: 1 year (through December 2025); extension possible up to 36 mos.
Essential Duties and Responsibilities:
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.
Qualifications:
Bachelor's in Science, Engineering or related field.
5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment. Expertise in manufacturing processes, particularly upstream in drug substance, is highly valued.
5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
2+ years of project management experience leading multi-functional and/or multi-location team.
1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.
Quality Records: Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Manufacturing and cGMP knowledge / experience.
Strong team leadership and facilitation skills are essential for coordinating projects efficiently.
Financial knowledge and business acumen.
Budget management, including purchase orders, financial forecasting, and adhering to financial targets and systems.
Demonstrated matrix management and influencing skills.
Demonstrated negotiation skills.
Operational Excellence proficiency and ability to drive continuous improvement.
Proficient project management skills.
Problem-solving and critical thinking.
Understanding of contractual requirements.
Technical writing and multi-level communication skills.
Demonstrated ability to lead effectively in collaborative/team environment.
Demonstrated ability to take initiative, drive action, and work under minimum supervision.5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.