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Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences

Somerset, New Jersey, United States

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 Sr. Advanced Analyst, Clinical Manufacturing Operations and Sciences as part of the Technical Development team based in Somerset, NJ. 

Role Overview

The Sr. Advanced Analyst, Clinical QC Operations and Sciences will be responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell and gene therapy pipeline assets to patients in need.  The successful candidate will collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate quality control laboratory for the purpose of producing Phase 1 products.  The following activities will include implementing testing and release for cell and gene therapy product candidates. Additionally, the successful candidate will lead quality control testing, complex investigations, and coordinate with external parties for testing

Key Responsibilities  

  • Create and author laboratory test methods and additional procedures necessary to operate a quality control laboratory at Phase 1 clinical standards.
  • Work cross-functionally with analytical development to perform method transfers and qualifications within the quality control laboratory.
  • Review and approve quality control test results, ensuring data integrity and compliance with cGMP and regulatory requirements.
  • Troubleshoot assay performance issues and support method optimization and development.
  • Schedule and execute routine testing of cell and gene therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations
  • Perform complex laboratory investigations including OOS, OOT, and deviations.
  • Author and review investigation reports, CAPAs, and change controls.
  • Drive continuous improvement initiatives to reduce error rates.
  • Represent QC in cross-functional meetings and project teams, providing subject matter expertise on analytical methods and regulatory expectations.
  • Coordinate with contract testing labs (CTL) to send samples for external testing and investigate out-of-specification results collaboratively with CTL.
  • Maintain the QC laboratory per internal procedures.
  • Train QC analysts on GMP and laboratory best practices.
  • Foster a culture of quality and compliance.

Requirements

  • BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.
  • 5+ years of experience in cell and gene therapy GMP quality control testing including operations, supervision, and strategy setting.
  • Knowledge and experience with cell and gene therapy manufacturing quality control tests
  • Familiarity with viral vector manufacturing quality control tests
  • Experience establishing and operating in a GMP environment
  • Familiarity with cell and gene therapy testing instruments
  • Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient
  • Experience working in cross-functional matrices
  • Excellent collaboration skills
  • Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
  • Familiarity with aseptic processing
  •  Knowledge and experience with cell and gene therapy manufacturing quality control tests
  • Familiarity with viral vector manufacturing quality control tests
  • Experience establishing and operating in a GMP environment
  • Familiarity with cell and gene therapy testing instruments
  • Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient
  • Experience working in cross-functional matrices
  • Excellent collaboration skills
  • Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
  • Familiarity with aseptic processing
  • Patient focus is a must

#Li-JR1

#Li-Hybrid

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.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: 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 voluntary 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 voluntary 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.

Pay Range (Base Pay):

$107,482 - $141,070 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors 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.

 
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.

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I (the candidate) enter into this Non-Disclosure Agreement (the “Agreement”) with Legend Biotech USA Inc. (the “Company”), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me.

  1. Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below.  I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a) not use or disclose any Confidential Information; (b) keep all Confidential Information confidential at all times; and (c) not copy, reproduce or modify any Confidential Information.
  2. Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know-how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure.
  3. Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer.  I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public.
  4. Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies.
  5. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California.  This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

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