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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Supply Chain Manager
Remote, CA US
Posted: 11/21/2024
2024-11-21
2025-01-08
Employment Type:
Contract
Job Category: Supplies/Logistics
Job Number: 4156
Job Description
The Supply Chain Manager (Demonstration Devices) manages contract manufacturing organizations (CMOs) that produce Demonstration Device kits in support of enhancing the injection experience with medications.
Responsibilities include preparing requests for proposals, preparing statements of work, negotiating agreements and ultimately managing the production activities at the CMOs. Work will also involve ensuring shipments are in compliance with Import and Export regulations and are received in a timely manner. This person will collaborate cross-functionally and with multiple stakeholders across all the company's sites Globally for success.
Responsibilities:
Qualifications:
Responsibilities include preparing requests for proposals, preparing statements of work, negotiating agreements and ultimately managing the production activities at the CMOs. Work will also involve ensuring shipments are in compliance with Import and Export regulations and are received in a timely manner. This person will collaborate cross-functionally and with multiple stakeholders across all the company's sites Globally for success.
Responsibilities:
- Maintain a detailed database of orders, ensuring quality in tracking and order management
- Participate in the selection process for Commercial CMOs.
- Prepare requests for proposals and statements of works, then ensure these are delivered in a timely manner to teams ordering devices.
- Collaborate with Legal and Finance to negotiate agreements with CMOs, as needed.
- Coordinate, oversee and document activities related to manufacturing of commercial demo devices (i.e. batch record production & review, scheduling production with vendor, etc.)
- Identify activities or events that may critically affect the availability of demo devices and act on or relay that information to appropriate level of management
- Maintain current, accurate and complete manufacturing files (hard copy & electronic, as appropriate)
- Review shipment requests for accuracy and completeness prior to processing. Ensure PO is received from team and delivered to shipping partner
- Coordinate and document activities surrounding complaints, excursions, or deviations received from sites or vendors
- Present metric updates to management and project stakeholders.
- Lead regularly scheduled meetings with partners and vendors
- Participate on audits of third party suppliers
- Handle confidential information and perform duties in strict confidence
- Ability to multitask with varying priorities
- Other Duties as assigned.
Qualifications:
- 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
- 3 -5 years pharmaceutical/biotech industry experience in manufacturing/supply chain management
- Process chemistry and API manufacturing experience preferred if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on Drug Product manufacturing
- Previous supervisory skills are a plus (management of staff).
- Good knowledge and demonstrated practice of ICH/cGXP Guidelines
- Experience with regulatory submissions is a plus
- Proficient in Microsoft Outlook, Word & Excel
- Prior commercial launch experience desirable
- Prior experience with SOX Compliance desirable
- Prior experience with use and implementation of ERP systems desirable
- Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
- Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure
- Must be highly organized and possess excellent attention to detail
- Must have strong oral, written and interpersonal communication skills
- Motivated, self directed, able to work autonomously and have a proven ability to work in a team environment