About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
The GEO Supply Chain Operations Associate will serve as an integral member of the Global External Supply Chain Operations team who have responsibility for and play a key role in supporting external Contract Manufacturing Operation (CMO) activities relating to Clinical drug products. They will help coordinate starting material and drug product and finished packaged goods supply needs between CMOs and internal teams to ensure that all product supply needs are defined and met. The candidate will be required to work closely with a cross-functional team and coordinate activities between Supply Chain, Quality, MSAT and the CMO. The GEO Supply Chain Operations Associate will work with the Process Team Owner, GEO.
Responsibilities:
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Manage ERP aspects for production efforts at CMO & Monitor and manage inventory levels of drug substance, drug product, finish goods and components as applicable at CMO site.
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PO and Invoice Management – generation, and coordination of POs
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Shipment Management – Form completion, shipment coordination, inbound & outbound, DS/DP/bulk packs & samples
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Inventory Reconciliation – manage monthly reconciliation process for relevant CMOs, prepare for and be primary SME/point of contact for inventory audits
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Coordination of reference standard supply with the relevant CMOs
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Coordination of annual stability samples with Novato and the relevant CMOs.
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Accountable and responsible for maintaining accuracy of Tier 2 Master Data (planning and GMP production recipes, quality parameters, dispensing and sourcing rules, planning attributes, formulas, and routings) for Planning and GMP Production Recipes and Formulas (Not process instructions).
Experience:
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Minimum requirement of 3-5 years in Operations, Supply Chain or Quality.
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BS/BA degree; life sciences, business, or supply chain management
Required skills needed to accomplish the responsibilities/essential functions include:
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Will have a good understanding of the processes/unit operations assigned to the team.
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Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
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Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
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Strong written and verbal communication, commercial acumen.
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A high level of initiative and questioning skills are key role requirements, as well as strong organizational skills.
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Experience in supply planning or inventory management.
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Experience in inventory reconciliation.
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Working knowledge of GXP regulations.
Desired Skills:
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Clinical Packaging Operations/Supply Chain
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Cold chain logistics knowledge
