Manager, Investigations

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Position Summary

The Manager, Investigations provides GMP investigation leadership to the Libertyville Vector Manufacturing Facility.  The Libertyville Vector Manufacturing Facility is a new facility, and the Manager will perform complex root cause analysis, work with stakeholders to identify corrective and preventative actions, facilitate impact assessments, and ensure the Manufacturing Science & Technology team is audit ready.  The Manager sits within the site Manufacturing Science & Technology (MSAT) department.

Responsibilities include, but are not limited to, the following:

• Conducts and manages the resolution of complex/multi-functional root cause investigations, including facilitation of impact assessments and CAPA decisions as a certified Lead Investigator
• Collaborates with cross-functional teams as a Lead Investigator including Manufacturing Operations, Process Engineering and Support, Facilities & Engineering, Quality Assurance, Supply Chain, and Quality Control
• Proactively manages the progression of investigations to timely and compliant closure per established KPIs utilizing Project Management and formal Root Cause Analysis tools
• Presents investigation findings to key stakeholders and the site Senior Leadership Team
• Trains and coaches colleagues on Investigation Program fundamentals and best practices such as GEMBA, Human Error Analysis, 6M/Fishbone, and Process Mapping
• Identifies, recommends, and drives improvements to Investigation organizations, processes, procedures, and the Quality Management System
• Aids in maintaining permanent inspection readiness; Actively supports regulatory inspections
• Stays current with industry trends and BMS standards, and participates in best practice forums consistent with function responsibilities

Qualifications and Education Requirements:

• Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required
• A minimum of 5 years’ experience in biopharmaceutical operations, or its equivalent is required
• Experience leading investigations, performing formal root cause analysis, and identifying corrective and preventative actions required
• Experience in cell therapy, vector, biologics, or vaccine manufacturing/support required
• Experience in cGMPs and multi-national biopharmaceutical/cell therapy regulations
• Excellent verbal and written communication skills to enable effective interactions with all levels of the organization; A work style that is decisive yet collaborative & approachable
• Strong priority-setting skills, with exceptional attention to detail and the ability to work on multiple investigations and projects at the same time
• Experience with Operational Excellence, Six Sigma, and/or Lean Principles is a plus

WORKING CONDITIONS (US Only):

Position may require working in Clean-Room manufacturing environment approximately 10% of the time.  Remainder of work is performed in an office environment.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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