Investigator Initiated Research (IIR) Associate II

Company: Unicon Pharma
Location: Lowell
Posted on: November 23, 2020

Job Description:

Job Description: The Andover Site Operations Management group is looking for an individual to fill a Lead Investigator position within the Andover Site Investigations group. The Andover Site Investigation group is responsible for overseeing investigations for all GMP 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. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. The individual will be expected to develop collaborative relationships with the operational leadership and staff in each suite and the appropriate Quality and Functional Area representatives in order to facilitate investigations using continuous improvement techniques. 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. Additional responsibilities and expectations include: 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. Be able to use that knowledge to investigate process deviations and atypical results and identify root cause Work with the appropriate people from both the quality and operational organizations develop a corrective action Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results A 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. 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.

Keywords: Unicon Pharma, Lowell , Investigator Initiated Research (IIR) Associate II, Other , Lowell, Massachusetts