• , US

Company:  Confidential

Job Title: Manufacturing Associate I/II

Job Number: 73606

Location: , US

Job Description

This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

Responsibilities

* Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing * Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols * Compiling data for documentation of test procedures and reporting abnormalities * Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results * Authoring, revising and updating standard operating procedures using the document change system * Maintaining broad knowledge of state-of-the-art principles and theories * Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations * Preparing technical summaries, protocols and reports * Initiating and closing deviations, investigations and CAPAs of moderate complexity; and * Performing special manufacturing and development projects

Required Skills

* Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field * 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting * Laboratory experience in mammalian tissue culture is required * Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry * Exceptional communication and interpersonal skills * Excellent organizational skills and attention to detail * Ability to work in a dynamic environment * Basic molecular biological and flow cytometry skills are preferred * Adaptable/flexible with work schedule with an ability to multi-task and prioritize work  * From time-to-time extended hours may be required with or without notice, dependent on the work needed Salary: 70-82k

Application Deadline: 2024-03-18

 

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