What are the responsibilities and job description for the Quality Assurance Specialist, Cell Therapy Facility - 1351018 position at Omni Consulting Services?
Title: Manufacturing Quality Assurance Specialist Cell Therapy
Job Type: Direct hire, full-time salaried role to join a leading bio-pharma company
Location: Near Boston, MA
On-site role
Our client is looking for a cell therapy leader with GMP manufacturing expertise to serve as Cell Therapy Manufacturing Specialist. This is an exciting opportunity to join the company's GMU and be part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions. Creativity, scientific thoroughness, entrepreneurial mindset, and ability to function in a complex environment are essential. This role is to support clinical manufacturing, as a cell therapy manufacturing specialist near Boston, MA.
Key Responsibilities
Support the manufacturing of cell therapy products for clinical supply.
Manage and execute Change Controls, LIRs, OTN and site deviations.
Work cross-functionally and in collaboration with internal support departments and manufacturing suite to develop or update internal policies, procedures or steps, communicates changes and plan for execution.
Own, manage, and monitor functional area project and tasks: Campaign support and readiness, MFG process specific change controls, Deviations, CAPA’s, Laboratory Investigation Reports (LIR) and Validation activities.
Identify, escalate and document events and variances that deviate from normal operation; participate as needed in investigations.
Liaison with Metrology department to ensure equipment is calibrated in a timely manner.
Assume a leadership role and participate in clinical manufacturing related activities that involve sterile/non-sterile conditions in a regulated cGMP environment.
Basic Qualifications
High school diploma/GED, Biotech Certification/associate degree with a minimum of 8 years of industry experience or a bachelor’s degree in sciences, engineering or related discipline with a minimum of 5 years of industry experience or a master’s degree with a minimum of 2 years of industry experience.
Advanced technical knowledge of cell therapy manufacturing operations/ process.
Working knowledge and experience with Quality Systems including deviations and change controls.
Excellent communication skills.
Experience with GMP regulations and cell therapy.
Experience in GMP documentation and compliance.
Ability to operate and thrive in a fast-paced, high-growth environment.
Preferred Qualifications:
Experience in operational excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, SMED etc. preferred.
PMP, Lean Six Sigma Green certification.
Direct experience in cell GMP manufacturing facilities with expertise in CAR-T, NK cell therapy.
Involvement in delivering a cell therapy-based product into clinical development.
Strong skills in change management.
Job Type: Direct hire, full-time salaried role to join a leading bio-pharma company
Location: Near Boston, MA
On-site role
Our client is looking for a cell therapy leader with GMP manufacturing expertise to serve as Cell Therapy Manufacturing Specialist. This is an exciting opportunity to join the company's GMU and be part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions. Creativity, scientific thoroughness, entrepreneurial mindset, and ability to function in a complex environment are essential. This role is to support clinical manufacturing, as a cell therapy manufacturing specialist near Boston, MA.
Key Responsibilities
Support the manufacturing of cell therapy products for clinical supply.
Manage and execute Change Controls, LIRs, OTN and site deviations.
Work cross-functionally and in collaboration with internal support departments and manufacturing suite to develop or update internal policies, procedures or steps, communicates changes and plan for execution.
Own, manage, and monitor functional area project and tasks: Campaign support and readiness, MFG process specific change controls, Deviations, CAPA’s, Laboratory Investigation Reports (LIR) and Validation activities.
Identify, escalate and document events and variances that deviate from normal operation; participate as needed in investigations.
Liaison with Metrology department to ensure equipment is calibrated in a timely manner.
Assume a leadership role and participate in clinical manufacturing related activities that involve sterile/non-sterile conditions in a regulated cGMP environment.
Basic Qualifications
High school diploma/GED, Biotech Certification/associate degree with a minimum of 8 years of industry experience or a bachelor’s degree in sciences, engineering or related discipline with a minimum of 5 years of industry experience or a master’s degree with a minimum of 2 years of industry experience.
Advanced technical knowledge of cell therapy manufacturing operations/ process.
Working knowledge and experience with Quality Systems including deviations and change controls.
Excellent communication skills.
Experience with GMP regulations and cell therapy.
Experience in GMP documentation and compliance.
Ability to operate and thrive in a fast-paced, high-growth environment.
Preferred Qualifications:
Experience in operational excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, SMED etc. preferred.
PMP, Lean Six Sigma Green certification.
Direct experience in cell GMP manufacturing facilities with expertise in CAR-T, NK cell therapy.
Involvement in delivering a cell therapy-based product into clinical development.
Strong skills in change management.
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