Description:
Note:
100% remote Can sit anywhere in the US - any time zone
Shift/Schedule: 8 5 pm, Monday - Friday
Ideal Candidate: 3-5 years of supply chain experience, ideally in the pharmaceutical or biotech industry, who’s comfortable driving end-to-end supply chain processes and leading a team. A Master’s degree is preferred, but a Bachelor’s in Operations, Materials Management, or a related field works too. The right candidate will be confident reaching out to people, managing vendor relationships, and handling global orders from start to finish. Advanced Excel skills are a must, with bonus points for experience in Smartsheet or SharePoint. Familiarity with SAP is nice to have but not required. Strong communication, attention to detail, and the ability to juggle multiple tasks will set you up for success in this role.
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
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- Ability to multitask with varying priorities
- Other Duties as assigned.
- Masters Degree Preferred: Bachelor’s in Operations, Materials Management, or a related field.
- 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).
- Manages staff in CMO’s
- Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):
- 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
Basic Qualifications
- Master’s degree and 2 years of experience
- Bachelor’s degree and 4 years of experience
- Associate’s degree and 8 years of experience
- High school diploma / GED and 10 years of [Job Code’s Discipline and/or Sub-Discipline] experience
Top 3 Must Have Skill Sets:
- Extensive Supply Chain Management background
- Strong communication skills
- Ability to multitask with strong attention to detail
Pay Rate- between $54 - $62/Hr. on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"