Manufacturing Technical Operations

Title: Senior Staff, Manufacturing Technical Operations

Location: Boston, MA Onsite

Duration: 6m

Experience with investigation tools

Nice to have = cell manufacturing & cell and gene therapy

Fast-paced environment

Strong communication skills

Need to be resourceful & proactive

JOB DESCRPTION:

This senior-level staff member on the MTO is responsible for complete ownership of quality records including, but not limited to Deviations, CAPAs, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of record ownership, triages, investigation, CAPA and change controls. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives, implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. This role will be pivotal for distributing and acting on metrics as well as supporting MTO intake and prioritization. This role is an on-site position based in our Boston location. This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines. This senior-staff members work one of the following 4 shifts:

• A1 Sun-Wed 7am-5:30pm
• A2 Sun - Wed 12:30pm - 11pm
• B1 Wed - Sat 7am - 5:30pm
• B2 Wed - Sat 12:30pm - 11pm

KEY RESPONSIBILITIES:

Triage manufacturing issues in real-time on manufacturing floor.

Use root cause analysis tools to lead and write investigations quality events in the cell manufacturing, quality control, material operations and facility operations functional areas.

Identify and collaborate with SMEs for triage, determine immediate actions and containment, document initial impact assessments.

Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.

• Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure.

Own deviations, CAPA, Effectiveness Check (EC) and Risk Assessment records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.

Promote MTO and QA- aligned compliance best practices to further establish operational and quality event record center of excellence teams.

Other duties and projects as assigned to meet departmental requirements and clinical timelines.

QUALIFICATIONS:

• 6 years progressive experience in pharmaceutical development and manufacturing.

BS in engineering, science or related discipline.

Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.

Experienced with technical writing and performing event investigations in a GMP-compliant environment.

Experience gowning manufacturing floor in Grade B environments