Specialist, QA Process Excellence at Legend Biotech

Raritan, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

99713.0

Posted On

09 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Oversight, Technical Expertise, Investigations, Deviations, Process Validation, Operational Improvements, GMP Compliance, Risk Assessments, CAPAs, Troubleshooting, Cell Therapy Processes, Manufacturing Execution Systems, Computer System Validation, Interpersonal Skills, Detail-Oriented, Microsoft Office Proficiency

Industry

Biotechnology Research

Description

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. Legend Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ. Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams. Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations. Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation. Assist in the development of process, operational, and quality improvements for manufacturing. Assist in the review and development of process-related protocols and documentation. Provide technical quality oversight for electronic batch records. Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems. Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions. Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities. Ability to work independently perform assigned tasks. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. May support CSV activities as needed. May support equipment qualification activities as needed. Drive continuous improvement. Requirements A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required. 5+ years relevant work experience or equivalent. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 5 years must include quality assurance experience. Strong knowledge of cell therapy processes strongly preferred. Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred. Experience with Computer System Validation (CSV) is a plus. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience reviewing/auditing GMP documentation. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and escalate to management when required. Detail-oriented and able to follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude. Strong proficiency with using Microsoft Office applications. #Li-RP1 #Li-Onsite The anticipated base pay range is $75,972—$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. 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.

Responsibilities

The Specialist, QA Process Excellence will provide quality oversight for the manufacturing process and associated technical activities in a cell therapy manufacturing plant. They will also assist in the development of process improvements and provide technical quality oversight for electronic batch records.