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Job Description

The role of Cryo-Logistics Specialist, Cell Banking will be to coordinate all domestic and international imports/exports of cell bank vials across the network and their third-party partners, out of Malvern, PA. The candidate's primary responsibilities will include, but are not limited to, the coordination of shipping, tracking, and supply of Master, Working, Analytical, and Development Cell Banks for clinical and commercial production, as well as analytical testing for J&J biopharmaceutical and cell therapy products.

Core Responsibilities:

-Provide support for the BioTD-API Cell banking organization by coordinating and leading all aspects of cryo-logistics

-Maintain and handle the day-to-day supply chain logistics for past, current, and future cell bank shipments

-Work autonomously in scheduling and coordinating shipments in a timely manner

-Work with shipping lead to issue/maintain/report financial documentation and records

-Support and ensure shipments imported into the Customs territories are in compliance with government agency requirements around import/export including shipping documentation, relevant license determination and application, Harmonized System Code (HS) classification, valuation, and other key trade compliance areas such as Harmonized Tariff Schedule Codes (HTS), UN Codes, BioSafety Level (BSL), and Risk Groups (RG) for materials being shipped

-Collaborate with the North American Regional Trade Compliance Operations team in preparation of imports and exports

-May author, review, and approve technical documents, SOPs, and WI's associated with shipping

-Collaborate with DPDS functional groups and Deliver partners on shared aspects of import/export activity for Janssen R&D (including Regional Trade Compliance, Global Trade Compliance, Valuation Center of Excellence)

-Establish and maintain an effective working relationship with all departments and affiliates to fully understand the business including its supply chain flows, products, systems, research, materials, applications, and other business resources

-Work with collaborating partners for transfers of assets

-Work with internal and external customers to ship cell banks and supply critical information as per their requirements

-Autonomy in execution of trade compliance rules and regulations, in executing imports and exports of cell bank vials

-Depth of knowledge with trade compliance, federal, DOT, USDA, Fish and Wildlife, guidelines for biologics

-Strong autonomy and able to drive processes forward individually while dealing with multifaceted external partners

-Able to think and work independently with minimal direction

-Strong problem-solving skills

-Ad hoc projects and other duties as assigned

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

-Bachelor degree in Supply Chain, Logistics, Biological Sciences, or other relevant fields

-Experience maintaining written records of work in form of (electronic) notebooks, procedural documents, protocols and technical forms

-Minimum 2 years of experience working within the pharmaceutical supply chain or logistics industry

-Experience tracking and coordinating shipments of inventory

-Microsoft Office experience -GMP, GDP, and GLP experience

-Knowledge of CRF 21 Title 21, Part 210

-Experience with cold chain logistics

-Experience with Dry vapor LN2 cryoshippers and/or dry ice cold chain

-General knowledge of BSL's, RG's, UN codes, and HTS Codes

-Experience in customs clearances and working with brokers null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.