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Senior Scientific Associate, MTIA - Boston - 17709

Boston, MA

Posted: 02/07/2023 Industry: Scientific and Life Sciences Job Number: 15302

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title:  Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
  • Duration: Temp
  • Job Location:  Boston MA
  • Pay Rate: $37-45/hr
  • Job#: bh15302
Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA)

position summary: 
The Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA) will have the primary responsibility is to support deviations, CAPAs, executed batch records and to provide continuous manufacturing PAT support at the Manufacturing Center.  The Senior Scientific Associate, MTIA reports directly to the Sr. Manager, MTIA.

Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
  • Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture.
  • Lead, write and review deviations and investigations for the VMC, including the Drug Product Facility, Facilities, Materials Management and the Kilo Lab.
  • Develop corrective/preventative action plans (CAPAs) through root cause analysis of deviations.
  • Author and submit revisions to controlled documents in support of GMP Operations, including Standard Operating Procedures, Work Instructions and Master Batch Records.
  • Review executed batch records to ensure compliance with GDP/GMP requirements.
  • Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.
  • Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes

Minimum qualifications:
  • BS/MS in chemical, mechanical, or material science engineering or comparable degree.
  • Two or more years experience working in a GMP manufacturing environment in the pharmaceuticals, biotechnology or medical device industries.
  • Understanding of cGMP concepts and general practices.
  • Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
  • Experience working in Quality Management System for regulated documents (e.g., Veeva or Trackwise) is a plus.
  • Formal training in root cause investigations and technical writing a plus.

 Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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