The Andover Site Operations Management group is looking for an individual to fill a Lead Investigator position within the Investigations group. The Andover Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites and laboratories 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 for the generation of high quality investigation reports. This position will report to the Manager of Investigations within the Site Operations Management Department.
The candidate will be responsible for performing thorough, detailed and timely investigations and for the generation of high quality investigation reports.
The individual will be expected to develop collaborative relationships with the operations, laboratory, quality, and other supporting groups 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 GMPs. Experience with and in depth understanding of cell culture and chromatography is highly desirable. The candidate will be expected to assist in continually defining and improving the philosophy tools for investigations to meet changing business needs.
Additional responsibilities and expectations include:
A BS or MS in a scientific or engineering discipline. Minimum qualifications of 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 use of continuous improve methodology preferred. The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.
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Eligible for Employee Referral Bonus
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