Legend Biotech
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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Supervisor, QC Micro
as part of the
Quality
team based in
Raritan, NJ .
Role Overview
The Supervisor, QC Micro is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.
Key Responsibilities
Ensuring adequate training (skills‑based, cGMP and safety) of associates within the department.
Raw material, in‑process, environmental/utility, and product release testing.
Scheduling of daily activities for personnel.
Investigation of laboratory non‑conformances (events, deviations, and invalid assays).
Maintenance, calibration and qualification of laboratory instruments and equipment.
Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on‑the‑job training requirements.
Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Other duties will be assigned, as necessary.
Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
Color Perception both eyes 5 slides out of 8.
Requirements
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
People management or leadership experience is required. Experience working with Quality systems is required.
Experience with quality support in clinical manufacture or NPI is preferred.
Extensive knowledge of chemical, biochemical and microbiological concepts is required. Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
Knowledge of cGMP regulations and FDA/EU guidance is required.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Comfortable with speaking and interacting with inspectors. Good written and verbal communication skills are required.
This position may require occasional travel to partner sites in NJ or PA as business demands.
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
The anticipated base pay range is: $93,463 USD - $122,670 USD
Benefits:
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Matched 401K
Flexible Spending Account
Health Savings Account
AD&D Insurance
Short‑Term Disability
Long‑Term Disability
Paid Maternity Leave
Paid Paternity Leave
Pet Insurance
Critical Illness Insurance
Hospital Indemnity Insurance
Accident Insurance
Legal Insurance
Commuter Benefits
Employee Assistance Program
EEO Statement
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug‑free workplace.
Referrals increase your chances of interviewing at Legend Biotech by 2x
Get notified about new Quality Control Supervisor jobs in
Raritan, NJ .
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Plainsboro, NJ $81,650 - $112,700 2 weeks ago
#J-18808-Ljbffr
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Supervisor, QC Micro
as part of the
Quality
team based in
Raritan, NJ .
Role Overview
The Supervisor, QC Micro is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.
Key Responsibilities
Ensuring adequate training (skills‑based, cGMP and safety) of associates within the department.
Raw material, in‑process, environmental/utility, and product release testing.
Scheduling of daily activities for personnel.
Investigation of laboratory non‑conformances (events, deviations, and invalid assays).
Maintenance, calibration and qualification of laboratory instruments and equipment.
Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on‑the‑job training requirements.
Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Other duties will be assigned, as necessary.
Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
Color Perception both eyes 5 slides out of 8.
Requirements
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
People management or leadership experience is required. Experience working with Quality systems is required.
Experience with quality support in clinical manufacture or NPI is preferred.
Extensive knowledge of chemical, biochemical and microbiological concepts is required. Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
Knowledge of cGMP regulations and FDA/EU guidance is required.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Comfortable with speaking and interacting with inspectors. Good written and verbal communication skills are required.
This position may require occasional travel to partner sites in NJ or PA as business demands.
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
The anticipated base pay range is: $93,463 USD - $122,670 USD
Benefits:
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Matched 401K
Flexible Spending Account
Health Savings Account
AD&D Insurance
Short‑Term Disability
Long‑Term Disability
Paid Maternity Leave
Paid Paternity Leave
Pet Insurance
Critical Illness Insurance
Hospital Indemnity Insurance
Accident Insurance
Legal Insurance
Commuter Benefits
Employee Assistance Program
EEO Statement
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
Legend Biotech maintains a drug‑free workplace.
Referrals increase your chances of interviewing at Legend Biotech by 2x
Get notified about new Quality Control Supervisor jobs in
Raritan, NJ .
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Plainsboro, NJ $81,650 - $112,700 2 weeks ago
#J-18808-Ljbffr