Lead Investigator - GMP Manufacturing

Lead Investigator - GMP Manufacturing Summary

The Andover Site Production Operations Team is looking for an individual to fill a Senior 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. As a senior level position within the Site Investigation group the responsibilities of this position will be multi-faceted.

They include serving as the primary lead investigator on complex investigations related to all production operations, laboratory, and production support areas. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. In addition, this position will be responsible for assisting the manager of investigations in transforming the investigation process on site including development and implementation of continuous improvement techniques.

Duties of this position may also include coaching and mentoring to staff members to enable them to meet their established timelines, work commitments and further their professional development. This position will report to the Investigations Team Manager.

• Responsible for performing thorough, detailed and timely investigations and for the generation of high-quality investigation reports
• Develop collaborative relationships with the operations, laboratory, quality, and other supporting groups in order to facilitate investigations using continuous improvement techniques
• Assist in continually defining and improving the philosophy tools for investigations to meet changing business needs
• Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues
• Have a detailed understanding of the processes and systems involved in the manufacture of biopharmaceuticals. 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
• Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently
• Act as Subject Matter Expert for the Investigations group, mentoring and providing guidance to other colleagues
• 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 a minimum of 10-15 years of relevant experience OR;
• Bachelor’s degree (preferably in a Science or Engineering discipline) with a minimum of 5-8 years relevant experience OR;
• Master’s degree (preferably in a Science or Engineering discipline) with a minimum of 3-6 years relevant experience
• Experience in the area of quality and compliance and a working knowledge of GMP
• Experience with and in-depth understanding of cell culture and chromatography is highly desirable
• Ability to coordinate and facilitate meetings, lead conversations, and influence teams

• Demonstrated expertise in pharmaceutical/biological manufacturing and/or laboratory operations
• Strong technical background in a cGMP and Quality environment
• Significant experience in leading complex investigations and cross-functional project teams
• Versed in navigating deviation management systems and business processes
• Demonstrated knowledge and application of 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

• This is a fully onsite role in Andover, MA
• Monday - Friday; 9 AM - 5 PM

Please note contractors are engaged to provide services to Pfizer temporarily in…