Teva Pharmaceuticals USA, Inc.

Manager Warehouse Biologics Operations

US-PA-West Chester
Requisition #
17-19681
# Positions
1
Experience (Years)
8
Category
Supply Chain - Warehousing

Overview

 

Located in West Chester, PA, Teva Biopharmaceuticals, USA is responsible for the development of CMC Biologics.  Teva Biopharmaceuticals, USA is a division of Teva Pharmaceuticals, with over $20 billion in annual revenue.  The rapidly growing staff of Biologics CMC, now nearly a hundred, specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters.  We currently are developing products in various stages of clinical development from IND through BLA filing.  TBU combines the financial stability of a large company with a small-company mentality emphasizing scientific-rigor and flexibility within a Regulatory and Quality context.  

 

We are current seeking a Manager of Warehouse Operations - Biologics.  Reporting to the Director Biologics Operations Support, the Manager of Warehouse Operations will be a key member of the Biologics Operations Support team working within a brand new state-of-the art biologics manufacturing facility located in West Chester, PA.  We are seeking an experienced and self-motivated person to play a major role in the overall success of Warehouse Operations within the Biologics Department.

 

Responsibilities

Manage Warehouse Operations to include:

  • Revise and Maintain Standard Operating Procedures in support of cGMP Warehouse Operations within Biologics
  • Formalize and Manage the Biologics Shipping Department that will ship material domestically and internationally such as cell banks, Bulk Drug Substance and Drug Product at controlled temperatures
  • Establish procedures for the import and export activities for international movement of materials and equipment within Biologics in conjunction with Customs & Trade Compliance
  • Formalize and Manage the Biologics Receiving Department for the receipt of cGMP and non-cGMP material such as raw materials, supplies and equipment
  • Establish and Maintain Inventory Control Management that will monitor and maintain cGMP and non cGMP materials; perform cycle counts, perform inventory reconciliation during inventory discrepancy and staging of raw materials, consumables and supplies
  • Overall maintain a cGMP and EH&S compliant Warehouse Operations department

The incumbent will:

  • Interface with Manufacturing, Quality Assurance, Quality Control, Procurement, EH&S, Facilities and Scale up operations
  • Support technology transfers and operational preparations
  • Perform Deviation investigations, change controls, Laboratory Investigations and CAPA (corrective action preventative action) within Teva’s Trackwise system
  • Have a complete knowledge of and be able to maintain cGMP compliance in a biopharmaceutical industry
  • Establish procedural and operational controls
  • Initiate, review, approve and facilitate change controls
  • Maintain a functional and compliant operations and warehouse area
  • Ensure that all equipment calibrations as well as preventive maintenance is scheduled
  • Present operational updates and data within group meetings as well as in departmental meetings as needed.
  • Create and maintain KPIs
  • Maintain accurate documentation, compliant with cGMP guidelines.
  • Lead a small warehouse staff.  Coach and mentor staff as needed

 

Qualifications

REQUIRED QUALIFICATIONS

  • A minimum of High School Diploma/GED
  • 8-10 years of combined experience in shipping / warehouse operations and cGMP operations within the biopharmaceutical / biotechnology industry.
  • 7+ years of Import/Export experience of Biologics to include: DOT Hazard Waste Manifest certification; US DOT 49 CFR Hazard Material Transportation certification; IATA/ICAO Dangerous Goods Receipt certification; Certification in Shipping Dry Ice in Transit
  • Experience working within cold chain solutions, such as shipping configurations for controlled ambient, 2-8°C, -20°C, -40°C and -80°C temperature controlled materials.
  • Hands-on experience within cGMP operations and cGMP inventory management controls at various scales
  • Understand and apply cGMP principles to both Supply Chain and cGMP warehouse operations
  • Experience with writing SOP’s and developing GMP documentation
  • 7+ years leadership experience with junior staff
  • Clearance to drive company vehicles
  • Excellent oral and written communication skills

 

PREFERRED QUALIFICATIONS:

 

  • BS in biology or equivalent in a related life-sciences field (Experience can be substituted)
  • 10+ years of experience in biologics logistics, supply chain and warehouse operations
  • 10+ years (individually or combined) of experience in cGMP operations and / or manufacturing sciences in the biopharmaceutical / biotechnology industry
  • Experience with cGMP facility start-up and subsequent qualification activities
  • Extended knowledge of import and export of Biologics, Bulk Drug Substance, and Drug Product
  • APICS CPIM or CSCM (or equivalent) certification

           

 

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