ProKidney, LLC Hiring for Sr. Manager, Logistics Job at Winston-Salem, NC Full Time

JOB DESCRIPTIONPOSITION TITLE: Sr. Manager Logistics

REPORTS TO: HEAD OF SUPPLY CHAIN

• PRIMARY RESPONSIBILITIES:

Responsible for managing ProKidney’s global distribution and import/export process in support end-to-end logistics activities for ProKidney’s cell therapy product.ESSENTIAL FUNCTIONS:

• Coordinate and monitor all shipment activities initiated by ProKidney directly, or at the request of the CRO.
• Manage global shipment schedule for all ProKidney inbound and outbound shipment requests.
• Ensure all necessary documentation is prepared and coordinated between sites.
• Resolve shipping-related issues with freight forwarders and customs brokers.
• Monitor critical shipments across each leg of transport as required.
• Maintain courier and lane specific metric control plan.
• Report and investigate shipping incidents with Quality Assurance.
• Support the evaluation, selection, and quality audits of logistic providers.
• Create a process for tracking shipment requests, shipment processing, shipment receipt and exception management that aligns with internal and external requirements
• Utilize visual management tools to provide customer and stakeholder visibility to all shipment requests. (Excel, Tableau, PowerBI)
• Interface with a diverse team across Clinical Development, Manufacturing, Supply Chain, Quality, as well as external partners to support the coordination of inbound and outbound logistics activities.
• Provide input to the development of Investigational Product (REACT) study documents, including distribution instructions, import licenses, etc.
• Ensure appropriate documentation of IP (REACT) supply activities is provided to clinical trial teams for the Trial Master File
• Serve as main contact with CRO on all cold chain issues; own the Logistics Management Plan (LMP)
• Develop Preferred Provider relationships with key service provider companies and work with them to implement ProKidney standards; perform vendor management and oversight activities
• Maintain a list of harmonized tariff codes applicable to ProKidney products
• Liaise with ProKidney Finance to ensure that insurance coverage and vendor contracts are aligned with global distribution risk
• Liaise with ProKidney Finance to ensure ProForma invoices are maintained and up to date regarding valuations and HS codes.
• Perform shipper qualification and lane validation as required by ProKidney
• Generate and maintain SOPs related to GDP (Good Distribution Practices) in support of all GMP and non-GMP products in the ProKidney Supply Chain
• Promote a risk conscious approach to operating a supply chain in current times

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s degree in Logistics, Transportation, Engineering, Business, or a related field
• 5+ years of experience in logistics (shipping and receiving) or related industries
• Previous leadership and/or training experience
• Knowledge of ISO or other quality management systems
• Experience with TPM, Lean Manufacturing and Six Sigma systems
• Attention to detail and accuracy in maintaining records
• Strong customer service, organizational and administrative skills
• Strong understanding of cold chain management
• Knowledge and understanding of international pharmaceuticals shipping requirements
• Additional specific qualifications in clinical supplies demand and logistics/ or planning management including and APICs, CPIM, and related processional certifications preferred
• Self-motivated and willing to accept responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

Job Type: Full-time

Pay: $110,000.00 – $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Winston-Salem, NC: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have experience working in a GMP environment
• Do you have experience with cold-chain logistics?

Education:

• Bachelor’s (Required)

Experience:

• Logistics: 5 years (Required)

Work Location: One location