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.
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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits
Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company 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.
Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
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.
Top Skills
What We Do
Legend Biotech is a global, commercial-stage biotechnology company developing and manufacturing novel therapies. We explore and apply innovative technologies to deliver cutting-edge options for patients around the world.
Our corporate headquarters is located in Somerset, NJ, and our manufacturing footprint includes facilities in the United States, China and the Belgium.
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