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Bench Scientist I
Ref No.: 17-07261
Location: Andover, Massachusetts
Start Date / End Date: 01/08/2018 to 07/07/2019
Job Description: Associate Cleaning Chemistry Scientist

Candidate must have a BS/MS in engineering, biology, or related sciences (M. S. (unrelated) or BS +0yrs experience).
Technical Skills:
Candidate must have experience working in laboratory environment and have well developed hands on laboratory skills.
Candidate should have an understanding of cGMP systems and practices.
Candidate must be able to work across functional areas such as operations, engineering, validation, maintenance, quality and regulatory.
Good communication skills, verbal and written, are required.
Recent experience in the use of laboratory instrumentation and equipment, such as: gel electrophoresis; spectrophotometer, laboratory pipettors; conductivity & pH instruments, etc.
Experience with standard desk top software (i. e. Word & Excel). Experience with laboratory scale cleaning evaluations. Experience with full scale cleaning equipment (COP washers, Cleaning skids, etc).

Role Description:
Provide technical support to the manufacturing plan of record within the realm of cleaning chemistry, disposables, solution expiry, and process improvements within a biopharmaceutical manufacturing facility.

Candidate will work with the group senior leader to develop, implement and monitor cleaning chemistry, solution expiry and appropriate use of disposable components in the manufacturing process. Candidate will support the design, troubleshooting and qualification of biopharmaceutical manufacturing equipment in the realm of cleaning chemistry, disposables, solution expiry, and process improvements. Work includes drafting study plans and protocols in accordance with defined proprietary site strategies; performing hands-on laboratory studies; documenting execution of studies to GMP standards; engineering studies in GMP environments; analysis of study results; drafting study summary reports; collaborating with Pharmaceutical staff on review and approval of summary reports, Maximum Allowable Carryover Calculations, solution expiry evaluations, and Extractable and Leachable evaluation support. The position may require equipment history review, investigation and audit support, process/component improvement project support, and continuous improvement support.
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