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Sr. Technical Scientist II in Andover, MA at Allied Reliability Group

Date Posted: 7/13/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Andover, MA
  • Job Type:
    Science
  • Experience:
    At least 1 year(s)
  • Date Posted:
    7/13/2018

Job Description

This is a team leader role responsible for major aspects of the site validation program and reports directly to the leader of the site validation program.    This role provides technical support and leadership in the validation area in support of Andover’s mission of being the premier multi product biological manufacturing site responsible for both commercial and clinical production.    Specific areas of responsibility includes cleaning chemistry, disposables technology inclusive of extractable and leachables assessments, solution expiry and process improvements within a cGMP biopharmaceutical manufacturing facility.   This is a highly visible role and provides overall leadership in the area of cleaning chemistry not only to the Andover site but the entire biological manufacturing network. 



Responsibilities

  • Candidate will work to develop, implement and monitor the strategy and philosophy in the area of cleaning chemistry, solution expiry and assessment of disposable components in the manufacturing process, including extractable/leachable program. 
  • Candidate will support the entire validation life cycle for biopharmaceutical manufacturing equipment in the realm of cleaning chemistry, disposables, solution expiry and process improvements. 
  • Candidate will drive the strategy for the site as well as plan and prioritize required work to be completed. 
  • Responsibilities include designing study plans and protocols in accordance with defined proprietary site strategies and applicable cGMP standards and expectations in the area of cleaning chemistry in a multi product facility. 
  • The position requires the management of full time and contracted personnel. 
  • The position requires investigation and process/component improvement project support, and continuous improvement support.  Interaction with regulatory authorities during site inspections is a key aspect of this role. 


Qualifications

Qualifications:

  • Candidate must have a BS/MS in engineering, biology, or related sciences (M.S. +11yrs or BS +13yrs experience). 

 

Technical Skills:

  • Candidate must have experience working in a biopharmaceutical or pharmaceutical manufacturing facility 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. 
  • Strong technical writing skills and experience in experimental design. 
  • 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).

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