Supply Chain Manager | BioNJ Talent Services

Supply Chain Manager

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Supply Chain Manager will assist the Director - Supply Chain in a broad array of activities related to the overall distribution and logistics operations.

Primary responsibilities for this role will be in 4 key areas.

Serialization: This role will manage and coordinate the serialization and traceability of Amicus products with our contract manufacturers and distributors to comply with DSCSA and pending rest of world regulations. This includes performing validation exercises for system updates to comply with new country specific regulations.

Shipping and Logistics: The incumbent will be versed in domestic and international shipping requirements, the harmonized tariff code, and act as the point person to support compliant inbound and outbound shipments of products and materials. This includes performing distribution risk assessments using HAZOP or FMEA, the qualification of shipping lanes, as well as OQ / PQ activities.

Supply Chain Integrity: The Supply Chain Manager will support Amicus as a certified C-TPAT partner with U.S. Customs and Border Patrol by ensuring all C-TPAT commitments and responsibilities are met and maintained both by Amicus and Amicus supply chain partners.

Package Engineering: Manage packaging component development and improvement projects as it relates to new product launches as well as existing products. This includes package design, shipping tests, CR testing, usability testing, manufacturability, security features, etc.

Roles and Responsibilities
Coordinate the serialization of batches with CMO’s and distributors as required. Act as the subject matter expert for serialization regulations worldwide as they develop and become requirements.
Support day to day supply chain operations by enabling the movement of product and materials in a timely, efficient, and compliant manner. Including the preparation and review of shipping documentation to ensure compliance.
Coordinate internal and external requests for the shipment of products and materials to meet stakeholder expectations and drive expediting when needed.
Conduct supply chain risk assessments as it relates to global distribution and logistics.
Oversee the ongoing compliance with Amicus’s participation in the C-TPAT program administered by U.S. Customs and Border Patrol. This includes Amicus third party partners.
Develop and implement SOP’s related to serialization, shipping and logistics, and supply chain security (C-TPAT) to establish standard business processes.
Work with commercial, regulatory, Amicus external partners and suppliers to design, develop, revise, and improve commercial packaging components.
Work with Director-Supply Chain in developing a metrics program for Amicus global distributors.

Qualifications: 

Requirements
BS or BE in Supply Chain Management, Engineering, or related field.
PMP certification desirable.
APICS Certifications desirable.
5 years relevant work experience in the pharmaceutical industry or related health care sector.
Understanding of GMP, GDP, FDA, ISTA, and ASTM requirements.
Knowledge and experience with qualification of temperature controlled packaging.
Experience with Microsoft Office applications (Excel, PowerPoint, Word).

Experience and Skills
This position will liaise with multiple groups and strong verbal and written communication skills are a must to be successful.
The role is expected to make recommendations to improve supply chain logistics and suggest ways to streamline workflows for increased efficiency.
Self-motivation and a strong sense of ownership and accountability is expected.
A demonstrated ability to take assignments and projects from inception to completion independently is important for success.
Attention to detail is paramount.
Strong verbal and written communication skills are a must.

Travel
10-20%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other