Investigator Initiated Research Associate

• Job ID : 43012
  Location : Andover, MA
  Duration : 12 Months
  Job Title : Investigator Initiated Research (IIR) Associate

• The Andover Site Investigation group is responsible for overseeing investigations for allGMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture.
• The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
• This position will report to the Manager of Investigations within the Site Operations Management Function.
• Prior experience with investigations including conducting and writing investigations and in use of continuous improve methodology preferred.
• The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.
• The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
• The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations.
• Experience with and in depth understanding of cell culture and chromatography is highly desirable.
• They will be expected to assist in continually defining and improving the philosophy and justifications involved in investigations and to continually evolve to meet changing business needs.

Skills:

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues
• Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceutical.
• Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards

Experience required:

• 3-5 Years

Education:

• BS or MS, preferably in a scientific or engineering discipline preferable.
• A minimum qualifications to BS + 4-6 yrs experience or MS + 2-4 yrs experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment is required.