Downstream Manufacturing Associate GMP Operations

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POST DATE 9/17/2016
END DATE 10/18/2016

New England Biolabs, Inc. Ipswich, MA

Company
New England Biolabs, Inc.
Job Classification
Full Time
Company Ref #
361034
AJE Ref #
576206221
Location
Ipswich, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Join New England Biolabs as we expand our world-class product offerings to include GMP manufacturing capacity. NEB is in the process of constructing a new state-of-the-art GMP production facility in Rowley Massachusetts and is building a top-notch team to drive its construction, start-up, and operation. Bring your experience, enthusiasm, and desire to make a difference to this exciting opportunity!

New England Biolabs (NEB) is seeking a Downstream Manufacturing Associate GMP Operations. The successful candidate will work within an interdisciplinary group and will be focused on delivering products produced using cGMP processes on time and within budget

Primary Responsibilities:

Ensure downstream operations are conducted in compliance with cGMP standards and applicable regulations in collaboration with the QA Manager and Plant Manager
Generate products through downstream processing steps such as TFF, chromatography, column packing and testing, CIP steps etc, demonstrating total familiarity with the equipment and ensuring that manufacturing processes are performed according to validated SOPs using qualified equipment
Creation of required downstream batch record(s) and product specific SOPs, forms or other record
Review manufacturing batch records upon completion and initiate and investigate process deviations and resulting OOS investigations
Apply creative problem-solving to Buffer Preparation and Downstream processes driving a lean culture with a compliance mind-set