Senior Specialist, Investigations, Cell Therapy in Devens, MA

Role Summary

The Senior Specialist, Investigations, Cell Therapy provides investigation leadership to the Devens Cell Therapy Facility. The Senior Specialist will perform root cause analysis, work with stakeholders to identify corrective and preventative actions, and facilitate impact assessments.

Responsibilities

• Conducting and managing the resolution of root cause investigations, including impact assessments, and CAPAs as a Lead Investigator
• Collaborating with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
• Proactively managing the progression of investigations and CAPAs to timely and compliant closure per established KPIs
• Presentation of investigation findings to key stakeholders and site senior management
• Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
• Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections

Knowledge, Skills, Abilities

• Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions preferred
• Experience with Operational Excellence and Lean Manufacturing is a plus
• Experience in cell therapy, biologics, or vaccine manufacturing/support desired
• Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations desired
• Excellent verbal/written communication skills and ability to influence at all levels
• Ability to think strategically, and to translate strategy into action
• Ability to prioritize and provide clear direction to team members in a highly dynamic environment

Qualifications

• Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline plus 2-4 years' experience in biopharmaceutical operations, or its equivalent is required

Education

• Bachelor's degree in science, engineering, biochemistry or related discipline

Additional Requirements

• Working Conditions: Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.