Signature Biologics, as part of a suite of emerging biotechnology and research companies, focuses on the development and commercialization of regenerative based products. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing the products in US.
Essential Duties and Responsibilities:
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Perform manufacturing of products in a cleanroom environment according to the established procedures.
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Adequately use aseptic technique and meet quality standards implemented in the laboratory according to applicable regulations during manufacturing of products.
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Collaborate in meeting the goals of the different departments of the laboratory, whether production or quality control.
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Perform related duties as assigned by the Associate Director of Manufacturing.
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Maintain compliance with all company policies and procedures including proper handling of company documentation, work product, controlled documents, SOP's, specification sheets, and company Intellectual Property Confidential.
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Responsible for controlled area cleaning –pre/post clean and packaging as directed by the Laboratory Director.
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Must be able to speak, listen and communicate in a professional manner in all aspects of job.
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Assist with any issues related to consumables, disposables and reagents.
Education and/or Work Experience Requirements:
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Bachelor's degree in Biology or Life Sciences required.
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Experience in cell culture: isolation, expansion, and harvest.
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Experience using cell counters and/or flow cytometer.
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Experience in GMP manufacturing or with aseptic technique preferred.
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Excellent verbal and written communication skills.
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Excellent computer proficiency (MS Office – Word, Excel and Outlook)
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Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product
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Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
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Must understand global metric standard.
Physical Requirements:
Must be able to lift, carry, and move up to 50 lbs.
Must be able to work while fully gowned in clean room.
Must be able to work while standing for extended periods.