The Andover Site Production Operations Team 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 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 Investigations Team Manager.
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:
- Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues
- Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceuticals. Be able to use that knowledge to investigate process deviations and atypical results.
- Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards
- Ability to coordinate and facilitate meetings, lead conversations, and influence teams
- Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently.
- Drive/contribute to the completion of complex projects and take responsibility for a portion of the team’s milestones/deliverables.
- Exercise positive communication techniques to maintain relationships and gain consensus in group scenarios with multiple stakeholders.
- Promote adherence to root cause analysis and human error reduction tools
- High School Diploma with 6-10 years relevant experience OR
- Bachelor's Degree with 3-6 years relevant experience OR
- Master's Degree with 2-5 years relevant experience
- Science or Engineering field of study preferred
- Demonstrated experience in a pharmaceutical/biological manufacturing and/or laboratory operations
- Demonstrated technical background in a cGMP and Quality environment
- Demonstrated experience in leading investigations and cross-functional project teams
- Demonstrated experience with deviation management systems
- Experience in applying lean six sigma principles and continuous improvement methodology
This position will require time in a production, warehouse or laboratory environment. Must be able to wear the appropriate PPE.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position is first shift Monday through Friday. Flexibility to work outside of regularly schedule shift may be required to support business needs.
- Occasional travel may be required.
Other Job Details:
- Last day to apply: 13 OCTOBER 2021
- Eligible for Relocation Assistance: NO
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