BioTech/Manufacturing Project Manager

Baltimore, Maryland, United States · KW · Baltimore

Description

BioTech/Manufacturing Project Manager


Summary:

The Project Manager has total responsibility and accountability for the integration of the needs and requirements of the customer, QA, Regulatory, Manufacturing Operations and Engineering. The Project Manager leads the technical transfer of products by coordinating the execution of the transfer procedures, assisting production startup by communicating and negotiating client requirements, ensuring adherence to CGMPs and quality standards, and safeguarding company interests. The Project Manager coordinates all activities surrounding the ongoing manufacture of clinical and commercial products including, receipt of client supplied material, production control record generation, sample shipping, product shipping, invoicing and non-conformance resolution.


Responsibilities:

Supervisory Responsibilities:

Directly responsible for leading project teams consisting of other managers, supervisors and senior support staff in order to push products from introduction to manufacturing and commercialization. Responsible for the P&L for each project. Each project manager holds a client portfolio with oversight of ~20-30% of the revenue and associated profit for the site.



Requirements

Required:

Desired:

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