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Manufacturing Specialist
Job Description
Responsibilities:
Basic Qualifications:
Preferred Qualifications:
- Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure performance execution across the external manufacturing network.
- 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.
- 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.
- 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:
- High school diploma / GED and 10 years of Manufacturing experience OR
- Associate’s degree and 8 years of Manufacturing experience OR
- Bachelor’s degree and 4 years of Manufacturing experience OR
- Master’s degree and 2 years of Manufacturing experience OR
- Doctorate degree
Preferred Qualifications:
- Bachelor’s in Business Administration, Engineering, or Science-related field.
- 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.
- 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.
- Manufacturing and cGMP knowledge / experience.
- 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.