Teva Pharmaceuticals Manager Warehouse, Biologics Operations Support in West Chester, Pennsylvania
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.
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
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
Requisition # 17-19681
# Positions 1
Location US-PA-West Chester
Experience (Years) 8
Category Supply Chain - Warehousing
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.