Lead Investigator

Description

SCHEDULE: Monday - Friday 9am - 5pm

Role 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.

Role Responsibilities

• 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. 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.
• 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

BASIC QUALIFICATIONS

• High School Diploma with 10-15 years relevant experience
• Bachelor’s degree (preferably in Science or Engineering discipline) with 5-8 years relevant experience
• Master’s degree (preferably in Science or Engineering discipline) with 3-6 years relevant experience

PREFERRED QUALIFICATIONS

• 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