Overview
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. Legend Biotech is seeking a QA Investigations Lead III as part of the Quality team based in Raritan, NJ.
Role Overview The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.
Key Responsibilities
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Perform analysis on quality indicating data and identifying trends.
Provide oversight for trending of quality compliance metrics.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
Qualifications
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
A minimum of 4 years relevant work experience is required. Experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy, is preferred.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
Great attention to detail and ability to follow procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a must.
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
Must exhibit strong leadership skills and effectively develop others.
Ability to collaborate well with stakeholders, customers and peers.
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
Must be able to discern the criticality of issues and communicate to management regarding complex issues.
Ability to manage conflict and issues that arise with internal or external customers.
Compensation and Benefits The anticipated base pay range is $81,273 – $106,669 USD. Actual compensation may vary based on experience, skills, qualifications, and geographic location. Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits Benefits include medical, dental, and vision insurance, and a 401(k) retirement plan with a company match that vests fully on day one. Additional benefits include eight weeks of paid parental leave after three months of employment, and a paid time off policy with vacation, personal time, sick time, floating holidays, and eleven company holidays. Other benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Commuter benefits, family planning resources, well-being initiatives, and peer-to-peer recognition programs are provided to support a culture where employees can do their best work. Note: Benefits are offered to permanent full-time employees; contract employees are not eligible.
EEO Statement Legend Biotech is an equal employment opportunity employer. We do not discriminate based on race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable laws. Employment is at-will and may be terminated at any time with or without cause or notice. Legend may adjust base salary or other compensation at any time based on performance or market conditions. For information related to our privacy policy, please review Legend Biotech Privacy Policy.
#J-18808-Ljbffr
Role Overview The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.
Key Responsibilities
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Perform analysis on quality indicating data and identifying trends.
Provide oversight for trending of quality compliance metrics.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
Qualifications
A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
A minimum of 4 years relevant work experience is required. Experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy, is preferred.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
Great attention to detail and ability to follow procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a must.
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
Must exhibit strong leadership skills and effectively develop others.
Ability to collaborate well with stakeholders, customers and peers.
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
Must be able to discern the criticality of issues and communicate to management regarding complex issues.
Ability to manage conflict and issues that arise with internal or external customers.
Compensation and Benefits The anticipated base pay range is $81,273 – $106,669 USD. Actual compensation may vary based on experience, skills, qualifications, and geographic location. Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits Benefits include medical, dental, and vision insurance, and a 401(k) retirement plan with a company match that vests fully on day one. Additional benefits include eight weeks of paid parental leave after three months of employment, and a paid time off policy with vacation, personal time, sick time, floating holidays, and eleven company holidays. Other benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Commuter benefits, family planning resources, well-being initiatives, and peer-to-peer recognition programs are provided to support a culture where employees can do their best work. Note: Benefits are offered to permanent full-time employees; contract employees are not eligible.
EEO Statement Legend Biotech is an equal employment opportunity employer. We do not discriminate based on race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable laws. Employment is at-will and may be terminated at any time with or without cause or notice. Legend may adjust base salary or other compensation at any time based on performance or market conditions. For information related to our privacy policy, please review Legend Biotech Privacy Policy.
#J-18808-Ljbffr