GMP Logistics Specialist

Posted 12 Days Ago
Hiring Remotely in United States
Remote
Mid level
Biotech
The Role
The GMP Logistics Specialist is responsible for overseeing domestic and international logistics processes including shipment coordination, customs clearance, and maintaining compliance with GMP standards. The role involves collaboration with cross-functional teams, handling shipping records, and managing freight invoices while adhering to cGMP policies.
Summary Generated by Built In

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, \ProBio has a stable and high-yield viral vector platform.

Job Scope: 

This position is responsible for the successful execution of the ProBio domestic and international logistics experiences, including receiving, processing, coordinating shipment, and customer clearance, etc at GMP facility for clinical and commercial products handling.

Requirements: 

  1. Manage international end-to-end logistics process, including contracts for forwarding service, custom clearance & bonds, brokers
  2. Collaborate with cross-functional teams on scheduling, receiving, storing and shipping sales orders and customer-provided materials, domestically and internationally
  3. Provide customs and tracking support including but not limited to, importing customs clearance and maintaining customs annual bond, applying import and export license and permit, providing delay notification and tracking supports and processing customs clearance and duty invoices
  4. Serves as a hands-on resource in Shipping and Receiving, being able to communicate to other departments on shipping processes and procedures.
  5. Maintain shipping records in relevant systems
  6. Process freight invoices accordingly for various shipping activities
  7. Adherence to all QMS, cGMP, SOP and EHS policies and procedures.
  8. Perform other duties as assigned by management.

Qualifications: 

  1. High School Diploma or GED
  2. 3+ years of previous experience as a shipping, warehouse, distribution, etDc., required
  3. 2 years of experience in the pharmaceutical/biotech industry preferred
  4. Required to lift and move material physically
  5. Experience in managing cold-chain logistics of biological materials is preferred
  6. Physical requirements include bending, standing for extended periods of time, and frequent lifting of a maximum of 50 pounds
  7. May require working weekends, holidays, and overtime
  8. Basic knowledge of cGMP requirements preferred
  9. Experience drafting and revising SOP’s and documentation work preferred
  10. Basic computer knowledge (email, MS Office)

#PB

#LW



GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

The Company
HQ: Piscataway, NJ
883 Employees
On-site Workplace
Year Founded: 2002

What We Do

Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

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